La teranyina que sosté la financialització dels medicaments, la salut i la vida (2)

 Sick with “Shareholder Value”: US Pharma’s Financialized Business Model During the Pandemic

Als USA, la Inflation Reduction Act ha obert la caixa dels trons. La possibilitat que el govern pugui negociar els preus dels medicaments finançats públicament ha desesperat a la indústria que ha engegat una campanya de lobby inusual. Es tracta de protegir els preus alts perquè altrament no hi haurà innovació, això diuen. Però malgrat aquesta campanya, fa pocs dies el WP ja deia que no se n'han sortit i que estem propers a grans canvis, que es resumeixen en aquests 6:

1) Drug price negotiation

2) A cap on out-of-pocket spending

3) Lower prices for insulin

4) Free vaccines

5) Inflation penalty for drug manufacturers. 

6) Extra help for the most vulnerable

El govern vol estalviar fins a 100.000 milions $ en aquests propers anys. I destacaria especialment, això de que si volen augmentar el preu més que la inflació (d'aquells medicaments ja en el mercat) hauran de fer descomptes al finançador públic. Dissuasió per tant de provocar preus excessius.

I aquí és on entra Wall Street que ho rebutja de dalt a baix i que ho veu com una amenaça al model de financialització que ha funcionat fins ara. Diuen que fins a 100 medicaments ja no arribaran al mercat. I aquesta amenaça no creïble no és certa perquè sabem això:

Data for the 474 corporations included in the S&P 500 Index in January 2022 and publicly traded from 2012 through 2021 reveal that these corporations distributed $5.7 trillion as share repurchases during the 2012-2021 fiscal years, representing 55 percent of net income, and $4.2 trillion as dividends, an additional 41 percent of net income.

Les recompres d'accions a la borsa per part de les companyies són un 13% superiors al que dediquen a la innovació.

As shown in Table 1, for the decade 2012-2021, distributions to shareholders by the 14 pharmaceutical companies that were among the 474 S&P 500 companies in the database represented 110 percent of net income,7 a larger proportion than the highly financialized 96 percent for all 474 companies. At 55 percent, the stock buybacks of the subset of pharmaceutical companies was the same proportion of net income as the 474 companies, but, at 54 percent versus 41 percent, pharmaceutical dividends as a proportion of net income far exceeded that of all the companies in the dataset. The 14 pharmaceutical companies accounted for 3.1 percent of the revenues of all 474 companies but 6.6 percent of the net income, 6.6 percent of the buybacks, and 8.8 percent of the dividends. The $747 billion that the pharmaceutical companies distributed to shareholders was 13 percent greater than the $660 billion that these corporations expended on research & development over the decade.

En aquest article de Lazonick hi trobareu molts més detalls sobre com ha canviat el model de negoci amb la biotecnologia. Si amb el model anterior el paper de la borsa era el típic de separació de propietat-control, en el nou les opas eren la forma de control per part de fons de capital-risc i després el paper del NASDAQ va oferir opcions d'entrada i sortida que abans no existien. L'article ho explica magníficament, no ho he vist enlloc més. La interacció de les recompres d'accions amb retribució escandalosa als directius de les companyies farmacèutiques esdevé una cosa mai vista a cap altra indústria.

Any 2021, el màxim directiu de Regeneron va ingressar 452 milions de $. No cal dir res més, tota la taula és una desmesura.

Què cal fer segons Lazonick?. El canvi en la regulació de preus és només el primer pas. Cal prohibir la recompra d'accions, deslligar el pagament dels directius dels valors de l'acció a borsa, posar representants dels accionistes al consell, reformar la fiscalitat de les empreses, encoratjar carreres professionals. 

Molta feina per endavant si es vol capgirar la tendència de financialització dels medicaments que vivim. Altrament, un avís, tot el que als USA es disminueixi com ingressos, voldran que sigui compensat amb fons provinents d'altres països. Per tant cal estar alerta als moviments propers i avançar-se als esdeveniments.

 

De què depèn el preu dels medicaments oncològics?

 Reporting reimbursement price decisions for onco-hematology drugs in Spain

Sabem que el 90% dels medicaments oncològics avaluats a Espanya són finançats amb fons públics, i tenen un preu 15 vegades superior al preu mitjà dels nous fàrmacs no relacionats amb el càncer. El 2021, els costos dels medicaments contra el càncer representaven el 16,9% del pressupost públic farmacèutic espanyol global, i el cost dels medicaments contra el càncer a nivell hospitalari ha crescut un 105,9% des del 2016. L'estudi de Miquel Serra a Lancet deia que era 3 vegades superior el preu, però es referia a altres països i medicaments, ben segur. Caldrà revisar-ho algun dia, de 3 vegades a 15 vegades hi va molt.

Ara en un interessant article (per guardar) es fa una revisió de quins són els factors a la pràctica que influeixen a la decisió de preu dels medicaments oncològics que es prenen a la Comissió Interministerial de Preus. I arriben a la conclusió que comparats amb el tractament standard, són més alts quan tenen una resposta més continuada, o són de duració fixa. I són més baixos quan tenen administració oral. Ho diuen així:

Higher prices were observed when the standard of care included for combinations, if there were references to long-lasting responses, for fixed duration treatment compared to treatment until progression and treatment with lower frequencies of administration; lower prices were observed for oral administration compared to other routes of administration. Statistically significant associations were observed between prices and the median duration of treatment, the impact on patient autonomy, the ease of use of the drug, and the recommendations of experts

I llavors em pregunto, el preu hauria de tenir alguna relació amb el valor que aporten oi? Indirectament d'alguna manera ho deuen considerar. Però cal dir que malgrat la retòrica dels preus basats en valor, la pràctica va pel seu compte. A l'article diuen: 

 Recent studies show that even in countries with well-established technology assessment processes (such as the UK, Germany, France, and Switzerland), prices may still be considered disconnected from value. In fact, in countries such as France, Australia, or the UK, prices are only weakly associated with drug clinical benefits

I si els països que tenen organitzada l'avaluació econòmica passa això, imagineu-vos els que no la tenen, com és el cas. En definitiva, que no sabem quins són els factors que fan que el preu sigui un o altre. Els autors de l'article proposen una metodologia, MCDA-Evidem, i jo crec que malauradament tot quedarà en no-res a curt termini. Sempre he pensat que el regulador és el primer interessat en la discrecionalitat de les seves decisions perquè això fa augmentar el seu poder. I que la fina línia que separa discrecionalitat d'arbitrarietat resulta molt difícil d'identificar. En una presumpte democràcia, la transparència a les decisions públiques hauria de ser la norma. Som lluny.

PS. I per aquí no tenim cap competència per decidir el preu, només ens toca pagar. Queda clar?

Ahir al Sant Jordi Club, Parov Stelar, magnífic, únic, indescriptible. El gran creador del moment.

La financialització com a determinant de la salut

The Financialization of Health in the United States 

Més d'una vegada he confrontat el professionalisme amb l'ineficàcia de l'Estat i els desequilibris del mercat al sector salut. El que es coneix com a tercera lògica que va dir Freidson. Les tres peces clau del professionalisme són: l'hegemonia del benestar del pacient, el principi d'autonomia del pacient i el principi de justícia social. La dinàmica dels incentius porta a conflictes d'interès on l'objectiu de benefici es contraposa als criteris anteriors, i especialment al primer.

A un article recent del NEJM podem veure com el professionalisme va de baixa als USA i es veu minoritzat fruit de la financialització de la salut, entesa com el procés d'influència dels mercats financers i les seves elits sobre el sector. La financialització implica la transformació d'empreses i productes sanitaris  en actius comercialitzables i transmissibles pels quals el sector financer pot acumular capital. La financialització representa una nova forma de propietat i control dels actius del sector sanitari en la mesura que els mercats financers demanen l'obtenció de beneficis a curt termini i la seva distribució a agents financers allunyats del sector salut.

Les dades que conté l'article demostren que la tendència ha estat i és creixent a hores d'ara. La financialització de la salut s'estén com una taca d'oli al USA. I alhora, això significa que hospitals, asseguradores i empreses farmacèutiques i biomèdiques es comporten com entitats financeres. Tal com vaig explicar, la teranyina que envolta la indústria farmacèutica ha convertit la innovació en noves molècules en actius financers, preocupa més l'extracció de valor que la seva creació. Allò que l'enyorat Uwe Reinhardt ja va apuntar sota el nom de "value shifting", quan el valor s'extrau dels membres d'una societat i és apropiat pels tenidors del capital.

Ho exemplificava amb aquest gràfic:

i ho explicava així:

In this exhibit, we assume that Acme Inc., possibly a pharmaceutical company, has developed a new product that is highly valued by the rest of society. Let us call that value “social value.” Measuring it is a methodological challenge. At the conceptual level, however, we may think of it as follows: Acme, Inc. can sell the new product to each individual, prospective customer at that individual’s maximum bid price – the monetary expression of the value that individual puts upon a unit of the product. That bid price naturally varies among individuals, because their income and wealth varies and also because their desire for the product—economists call it “taste” for the product—varies.

If we added up these maximum bid prices across all individuals potentially interested in the new product, we might call that sum the product’s “social value.” In the exhibit, it is shown as the value-flow in pipe A. In many instances, the true social value might even be higher, if there are spill-over effects from the individual user of the new product to other members of society. That would be the case, for example, if the products cured an infectious disease.

Usually, in the real world, firms cannot extract from society all of the social value their products create. Even drug companies with government-granted monopolies usually capture only a fraction of total social value in the form of the firms’ sales revenue. That captured value is shown in pipe B of the chart. The firm distributes that captured value to its employees (pipe C), to its suppliers of other productive inputs and of credit (pipe D), and to government in the form of taxes (pipe E). The residual that is left over accrues to the firm’s shareholders (pipe F). It is the source of the wealth the firm bestows on them.

A major point to take away from the preceding discussion and the accompanying exhibit is that a firm adds net social value to society as a whole only through pipe A. If a firm’s policies do not add net social value, but its shareholders nevertheless are enriched by the firm’s decisions, the firm merely has redistributed already existing value from some members of society (for examples, customers or employees) to its shareholders.

Normally, neither politicians, nor the media, nor the general public pay much attention to the fraction of total social value (pipe A) that firms can capture as revenue (pipe B). In health care, however, that fraction can be quite controversial, as was seen in the public’s reaction to the pricing of high-value specialty drugs such as Gilead Sciences Inc.’s new drugs Solvadi and Harvoni.

En Reinhardt ja apuntava el 2016 a que els preus excessius dels medicaments representaven una extracció de valor. Malgrat no citava el terme financialització com a causa, a hores d'ara podem afegir i confirmar que la financialització també és un determinant de la salut. Una financialització que esvaeix el professionalisme en la medicina. Cal estar-ne atent, entendre com actua i tractar de moderar el seu impacte. Malauradament, en sabem encara poca cosa del que passa per aquí a prop. Caldria una anàlisi en profunditat, i crec que ens trobaríem amb més d'una sorpresa.

PS. Aquí podeu trobar un exemple d'avui de com els lobbys treballen per la financialització de la salut.

Quin hauria de ser el preu adient dels medicaments?

 The Right Price: A Value-Based Prescription for Drug Costs

Ara que la FDA acaba d'aprovar la primera teràpia d'edició genètica mitjançant CRISPR per anèmia de cèl·lules falciformes, ja sabem el preu que ha decidit VERTEX, l'empresa comercialitzadora, 2,2 milions $. A Catalunya poden haver-hi unes 240 persones afectades i per tant l'impacte pressupostari del cost del tractament seria de més de 500 milions (si el preu final fos el que diuen ara). Aquesta és la dimensió del problema que s'acosta. La EMA l'aprovarà el mes de març proper.

Quin hauria de ser el preu adient d'un medicament?. Bona pregunta per un moment com aquest.  Aquesta és precisament la qüestió que tracta un llibre de Peter Neumann et al. que he llegit recentment. Es tracta d'una obra per a tots els públics centrada als USA però que també va més enllà. L'índex ja dona una idea:

PART I. THE ECONOMICS OF PRESCRIPTION DRUGS

1.Introduction

2.The Prescription Drug Market

3.Proposed Solutions for Rising Drug Prices

4.Measuring the Value of Prescription Drugs

PART II. EXPERIENCES MEASURING A DRUG’S VALUE IN THE US AND ABROAD

5.Measuring Drug Value: Whose Job Is It Anyway?

6.Institute for Clinical and Economic Review

7.Other US Value Assessment Frameworks

8.Do Drugs for Special Populations Warrant Higher Prices?

PART III. GETTING TO VALUE-BASED PRICING FOR DRUGS

9.Improving Value Measurement

10.Aligning Prices With Value

11.The Path Forward

La tercera part m'ha interessat especialment perquè planteja qüestions sobre els QALYs que repetidament he explicat en aquest blog, i diu:

If QALYs were a person, they might receive a lot of hate mail. People complain that QALYs are not patient-focused, that they are used as rationing tools by health insurers, and that putting numbers on people’s health is dehumanizing. “The entire superstructure of the QALY methodology is built upon philosophical sand,” wrote one critic in 2019. As we have seen, the use of cost-per-QALY ratios by payers to inform drug coverage and pricing decisions attracts intense opposition in some quarters.

El racionament existeix però hipòcritament ningú en vol parlar, diu.  I els QALYs tenen problemes però,

A philosopher and ethicist, Peter Singer, has observed (with apologies to Winston Churchill), QALYs may be the worst way to measure health, except for all of the others.

I així és. Som davant d'un llibre d'interès, especialment per a reguladors acabats d'arribar al càrrec i no tenen temps de llegir i s'enfronten al pànic escènic. És un llibre relativament curt que ajudarà a posar les idees en el context acurat.

PS. Tinc la impressió que cal superar la lògica del preu i anar cap una concepció diferent de contracte públic de subministrament de teràpies. Ho he explicat en altres ocasions i en canvi aquest llibre no ho reflecteix.

PS. Tinc la impressió que estem davant d'una teràpia amb gran potencial d'efecte crida, molt preocupant. Encara som a temps per regular-ho i evitar que passi com amb els peruans i el CAR-T. O es fa abans o ja serà massa tard i es farà malament.

PS. Aquí teniu un exemple de recerca en un àmbit on ja s'ha trobat la solució, i per tant és inapropiat invertir-hi. Ara bé, algú no se n'ha volgut adonar i uns altres hi estan abocant diners. Trobo a faltar informes sobre recerca fútil.  Si voleu conèixer com s'ha arribat a la solució, ho trobareu aquí.

PS. Antic post sobre guerra injusta, per rellegir ara mateix.

 

L'equació fonamental de la hidroestàtica i els preus dels medicaments

The White House’s Latest Move to Rein in Drug Prices

Llegeixo a Time que el govern americà finança cada any 100 mil milions de $ en recerca i desenvolupament, i que un bon tros va cap a la indústria farmacèutica. I resulta que el president Biden s'ha adonat que hi ha una llei, la  Bayh–Dole Act, que diu que si una organització empresarial rep finançament del govern federal per desenvolupar un nou producte, el govern dels Estats Units té el dret de "participar" i controlar a qui llicencia el producte. En el cas de les companyies farmacèutiques, això vol dir que el govern pot donar la llicència per fabricar un medicament protegit per patent a una empresa genèrica, fent baixar significativament el preu del medicament. 

El tema fa temps que cueja, recordeu el preu de les vacunes COVID i la investigació pública en recerca, en vaig parlar fa dies. Llavors es va argumentar que els ciutadans nordamericans estaven pagant dues vegades, per una banda la recerca i alhora el preu de la vacuna. Ara el president s'ha adonat que hi ha una llei de 1980, que des de fa 43 anys permet llicenciar una patent quan hi ha hagut finançament públic.

Com funcionaria això? Doncs cal llegir el que diu la Casa Blanca en el seu informe. Primer parla de l'impacte de la concentració de mercat i com afecta el preu:

New research released by the Department of Health and Human Services (HHS) finds that a lack of competition in drug markets is highly correlated with higher prices. Among the highest priced drugs (i.e., those in the top 10% of price per prescription), 89% of small molecule drugs and 100% of biological products had only one manufacturer. Meanwhile, nearly three in ten individuals struggle to pay for the drugs they need.

 I després assenyala un conjunt de mesures raonables i clares. En destaco la relativa als preus:

Negotiating and lowering drug prices. Thanks to President Biden’s Inflation Reduction Act, the Administration has announced 10 prescription drugs for which Medicare will negotiate prices directly with participating manufacturers. These drugs cost people with Medicare $3.4 billion out of pocket in 2022. This builds on other progress to lower prescription drug costs. Individuals with Medicare can now receive certain vaccines for free under the President’s lower cost prescription drug law, which previously would have cost an average of $70 in out-of-pocket costs. The Inflation Reduction Act also capped the cost of insulin at $35 per product per month for almost four million seniors and others on Medicare with diabetes, which can lead to hundreds of dollars in savings for a month’s supply.

Per llei fins fa poc el govern no podia negociar preus, però la Inflation Act ho va canviar i ara com a gran cosa en negociaran 10 només, però són dels més importants. Alhora que assenyalen un camí nou, el de preus màxims. Convé recordar que el 45% del finançament dels medicaments és públic, i la despesa farmacèutica total és de 348 mil milions de $.

Definitivament, si tot això passa serà un canvi radical a la política farmacèutica nordamericana, que farà trontollar arreu, també a Europa. I és que això significa una erosió de benefici allà on el marge és més gran i cercaran formes de compensar-ho, per allò dels vasos comunicants, l'equació fonamental de la hidroestàtica. La pressió per augmentar els marges serà superior a Europa, si s'erosionen els beneficis als USA, i els preus a Europa poden augmentar. El regulador hauria d'estar atent i ser proactiu davant d'aquest nou escenari ben possible.

PS. Nota del dia. Imagineu un Estat que ha decidit posar un impost i dins hi ha un país que hi viu el 16% de la població. El 41% dels contribuents que paga aquest impost és d'aquest petit país, i el 44% dels ingressos també ho són. Hi ha 88.781 contribuents que han llepat i paguen 7.112 euros de mitjana. I després diuen en aquell Estat que som iguals davant la llei i que aquesta repressió fiscal és legal i no es pot fugir-ne, malgrat que tothom ja sap que marxar tant aviat com es pugui és l'única opció.

Lliçons sobre política farmacèutica (3)

Regulation, Innovation and Competition in Pharmaceutical Markets

Si voleu un llibre introductori que descriu amb precisió el mercat farmacèutic aquesta és l'opció del moment. Els conceptes habituals necessaris per moure's bé en aquest entorn són explicats amb tots els detalls.

M'ha interessat especialment el tema de pagar per retardar l'entrada dels genèrics, els acords de pagament invers, perquè s'explica amb tota claredat una pràctica vergonyosa de la indústria que ja coneixia però que em faltaven peces.

Es tracta d'això:

‘reverse payment’ patent settlement agreements (also called pay-for-delay settlements), because they provide for the patentee to pay the alleged infringer, rather than the opposite (considering the standard expectation that a defendant would pay a plaintiff to settle), with the aim of delaying its market entry. In other words, in its typical scheme, the brand-name drug pharmaceutical company enters into an agreement with the generic competitor to settle the dispute and to limit its market entry in return for a transfer of value.1 Such transfer can take different forms, including either a direct monetary payment or another form of valuable agreement (eg an authorised licensed entry at a specific date, distribution agreements, favourable terms in a side deal in which the originator company grants a commercial benefit to the generic company), or both. 

Aquest és l'índex del llibre: 

Introduction 1

I. The Different Faces of Pharmaceutical Markets 1

PART I

1. Regulating Entry 15

I. The Main Features of Pharmaceutical Markets: The Supply Side and the Demand Side 15

II. The Product Life Cycle and the Costs of Innovation 20

III. The Access to the Market: Regulatory Approaches 23

A. The European Regulatory Framework 23

B. The US Regulatory Framework 27

IV. Concluding Remarks 33

2. Regulating Exclusivity 34

I. The Interplay between Regulatory Exclusivities and Intellectual Property Rights 34

II. Intellectual Property Rights in the Pharmaceutical Industry: An Overview on the Role of Patents 35

III. EU Supplementary Protection Certificate and US Patent Term Restoration 41

IV. Regulatory Exclusivity 48

V. Research and Bolar Exemptions 52

VI. Exhaustion Doctrine and Parallel Trade 59

VII. Concluding Remarks 63

3. Regulating Prices 64

I. Pharmaceutical Pricing and Reimbursement Systems in Europe 64

II. The US System 70

III. Concluding Remarks 76

viii Contents

PART II

4. Competition Law Enforcement in Pharmaceutical Markets: An Introduction 79

I. EU and US Antitrust Rules: An Essential Overview 79

II. Antitrust Enforcement in the Pharmaceutical Sector 87

III. Market Definition 95

IV. Concluding Remarks 100

5. Reverse Payment Patent Settlements 102

I. The Recurrence of Reverse Payment Patent Settlements in Pharmaceutical Markets 102

II. Reverse Payment Patent Settlements in the United States 105

A. Earlier Case Law and the Actavis Ruling 105

B. Critical Issues after Actavis 109

C. Further Developments 113

III. EU Case Law on Reverse Payment Patent Settlements 119

A. Lundbeck 120

B. Generics 123

IV. Comparative Analysis 127

A. Legal Frameworks 127

B. The Antitrust Assessment 129

V. Concluding Remarks 134

6. Product Hopping 136

I. Pharmaceutical Product Reformulations 136

II. Product Hopping before US Courts 140

III. The EU Experience 146

IV. The Antitrust Assessment of Product Reformulation 151

V. Concluding Remarks 155

7. Excessive Drug Pricing 157

I. The Resurgence of Excessive Pricing Cases in the Pharmaceutical Sector 157

II. Excessive Pricing under EU Competition Law 161

A. Aspen 165

III. The US Approach 169

IV. The Role of Antitrust Enforcement on Excessive Drug Prices 176

V. Concluding Remarks 178

PART III

8. Further Interactions: Pharmaceutical Markets, Intellectual Property and Human Rights 183

I. The Right to Health and Access to Medicines and the Relationship with Intellectual Property Rights: An Overview 183

II. Compulsory Licensing 191

III. Concluding Remarks 196

9. Public Health and Public Interest in Competition Law 198

I. Public Health and Competition Law 198

II. Competition Law and Non-competition Interests 203

III. Concluding Remarks 208

Conclusion 209

Bibliography 213

Index 233

La competència a mercats farmacèutics protegits per patent

Enhancing competition in on-patent markets 

Algú pot pensar, si un producte farmacèutic està protegit per patent doncs llavors és un monopoli, doncs no. Pot haver-hi alternatives terapèutiques dins el mateix grup que es trobin en competència. I si això és així, llavors ens hem de preguntar quin és el nivell de competència que es produeix realment. 

L'OCDE acaba de donar resposta a la pregunta, i el missatge és que l'impacte en preus és molt limitat. Fins i tot es produeixen augments de preus en contextos on el nou producte no redueix quota de mercat dels anteriors ni el preu.

Aquestes són les conclusions:

 • There is mixed empirical evidence of the existence and impact of therapeutic competition in OECD countries. A review of the literature revealed only very limited evidence of the impact of competition between patented products on prices or market share, with a few studies reporting that the impact may not be discernible until several competing products have entered the market;

• No clear evidence of price competition was observed within those therapeutic classes in our sample with fewer than five therapeutic alternatives. In fact, over the period of the analysis the countries in our sample experienced significant price increases despite the market entry of multiple therapeutic alternatives within the selected drug classes, with prices of follow-on products often higher than those of the first-in-class. Later entrants were also observed to acquire market share without any decline in sales of the first-in-class product, regardless of whether they set a price higher or lower than that of the first-in-class. 

• Policies that define coverage, pricing, prescribing and procurement practices can theoretically shape the extent to which product alternatives compete. 

• While most countries assess comparative effectiveness of alternative products within a therapeutic class, the extent to which that assessment informs policy varies widely, and the extent to which these analyses are used to promote on-patent competition is unclear. 

• While tendering is increasingly used for procurement of medicines, few countries apply it to patented products in both inpatient and outpatient sectors;

• Price competition does not appear to be the default dynamic resulting from successive market entries. Policy settings around pricing, procurement and formulary management must therefore be designed to facilitate and promote competition between patented products.

I aquestes són les quatre recomanacions:

• Ensuring alignment of pricing and procurement policies to create a pro-competitive environment. 

• Optimising the use of formulary management. Payers and health insurers in only a few countries use formulary management to foster competition as leverage in price negotiations in exchange for preferred status on formularies or in clinical algorithms. Where therapeutic alternatives exist, preferred status can be used to encourage competitive pricing as it significantly impacts market share;

• Promoting the use of tendering by class or indication for the treatment of a particular condition; and,

• Utilising evidence of comparative effectiveness to build recognition among the clinical community and competent authorities of the potential value of therapeutic alternatives in driving on-patent competition.

El suggeriment a tenir en compte per al regulador-finançador: utilitzar licitacions enlloc de preus en grups terapèutics equivalents patentats. En un context de preus confidencials, aquesta recomanació encara pren més volada. Se li ha girat feina, si en vol tenir.

 

 

 

Nirvis (2)

 High drug prices are not justified by industry’s spending on research and development

Les dues retòriques per justificar els preus alts dels medicaments són: cal recuperar la inversió en recerca, i cal relacionar el preu amb el valor que aporten. La primera d'aquestes dues retòriques és la que s'explica a un article de BMJ. Són dades conegudes mostrades d'una altra manera. A la meva conferència a la Reial Acadèmia de Medicina del novembre passat ja ho vaig reflectir. La segona retòrica, la del valor, també apareix d'esquitllada a l'article, però sens dubte és el tema que es vol enfatitzar en aquest moment. 

El relat dels preus alts per recuperar inversió ja sap tothom que no se sosté per enlloc, i no cal donar-hi més voltes. I quan entrem en la retòrica del valor aquí hi podem trobar de tot, regles de rescat incloses. Per tant entrem a un camp minat, terres fangoses i sense cap concreció d'on anirem a parar.

Al final donen recomanacions al govern:

• Making national patent systems more stringent to avoid rewarding chemical novelty and inventiveness independent of added therapeutic value

• Clear communication by public health authorities to lay out health needs focused research and development priorities and the strategic use of public research funding to support them

• Smarter allocation of public research funds with retention of (partial) ownership that can be leveraged to pursue public health objectives, including affordable pricing

• Raising evidence standards for market authorisation by requiring companies to conduct comparative clinical trials designed to establish added therapeutic value whenever possible, and

• Reforming pricing and reimbursement systems to reward companies that develop drugs that deliver clinical benefit and discourage me-too and evergreening strategies

Llegiu-vos l'article i guardeu-lo. S'apropen els medicaments per l'hemofília i en sentirem a parlar dels seus preus i de l'impacte pressupostari. L'argument no serà la recerca, serà el valor que pressumptament aporten. Veig nirvis per totes bandes.

Banksy

El pensament il·lusori sobre els preus de les teràpies genètiques

Sources of Innovation in Gene Therapies — Approaches to Achieving Affordable Prices

Miro el NEJM  i em trobo un article sobre com pagar la innovació farmacèutica que ve, tema molt important del que no s'en parla prou. I allà es recorda el seu origen: 

All gene therapies approved in the United States thus far have their origins in academic institutions or spinoffs from such institutions that developed indispensable know-how and underlying forms of  technology

 I també recorda l'alt preu pagat per l'adquisició d'aquestes noves empreses amb l'expectativa de preus desorbitats.

Pharmaceutical manufacturers have actively participated in latest age clinical development and testing of the approved gene therapies, and a few have played major roles in expanding the market for these therapies, often by buying smaller companies. The costs associated with these acquisitions and licensing agreements can be very high. For example, Gilead was reported to have acquired Kite Pharma (which had rights to axicabtagene ciloleucel and brexucabtagene autoleucel) for $11.9 billion, and Novartis acquired AveXis (which had rights to onasemnogene abeparvovec) for $8.7 billion. The costs of such intellectual property are largely driven by the absence of limits on drug prices in the U.S. market. The resulting high prices can impose an enormous acute financial burden on patients and payers.

I després explica què fer. Una primera opció seria produir acadèmicament teràpies genètiques. L'exemple CAR-T ens sonarà familiar, i cita Suïssa però s'oblida l'Hospital Clínic i de l'Hospital de Sant Pau:

 The cost to produce tisagenlecleucel, for example, was estimated at approximately $70,000 — a fraction of the therapy’s current prices in the United States and Europe. One approach would be for academic and other research institutions to conduct or contract out late-stage development activities — such as managing clinical trials, corresponding with and submitting applications to the FDA, and manufacturing — for publicly funded treatments that they discover. University hospitals in Switzerland have formed an alliance to manufacture gene therapies in-house to reduce costs and improve accessibility.

L'altra opció seria, llicenciar:

 Regulators and policymakers could encourage institutions that receive federal funding to engage in nonexclusive licensing for certain key platform innovations that are part of the gene-therapy processes they have developed, in keeping with their mission and in recognition of the public funding that supports such discoveries. Licensing to multiple manufacturers would spur competition, which could help improve the technology over time and contain treatment prices.

I la tercera, compra conjunta

A third approach would be to facilitate systemwide price negotiation for gene therapies. In industrialized countries that have mechanisms for drug-price negotiation, prices for such therapies are high but still generally lower than prices in the United States 

Més que opcions possiblement són desitjos. La darrera seria la mesura més definitiva de totes.  Les multinacionals són globals, els mercats locals. Però tot i així ens enfrontaríem a gestionar amb transparència la discriminació de preus per part dels pagadors i reguladors. Implica un govern planetari inexistent, i si existís potser l'altra part no voldria negociar...

En definitiva, d'això s'en diu "wishful thinking", pensament il·lusori. D'il·lusió també en viu el NEJM.

Imatge per guardar i ensenyar quan calgui explicar d'on venen les innovacions...

PD. Fa uns cinc anys vaig fer una conferència on vaig explicar com la farmàcia hospitalària s'enfrontava a un canvi en la funció de producció. I aquest canvi seria provocat inicialment pel receptor antígen quimèric per a les cèl·lules T, CAR-T. Es van sorprendre força. Els temps passa i confirma el que vaig dir. El que sorprèn és que no s'hagi formalitzat com a tal aquest canvi i no es plantegi un canvi organitzatiu profund on s'analitzin les economies d'escala i aprenentatge possibles.

Exposició a Barcelona

L'eficiència de l'atenció no presencial

The COVID-19 Pandemic and the Future of Telemedicine 

Els fets són toçuts i fan canviar comportaments quan menys t'ho esperes. I això és el que va passar durant la pandèmia. Havíem d'accedir al contacte expert amb metges i estava limitat. La telemedicina es va presentar com a solució efectiva a un problema real. Però no és que no hi fos abans, moltíssima gent es va adonar que existia "La meva salut" just en el moment de la pandèmia (1,5 milions d'altes el 2020). La infraestructura havia costat molt bastir-la però estava apunt. Algú es pot imaginar com s'haurien pogut gestionar els 9,4 milions de contactes realitzats només mitjançant TIC l'any 2020?.  Si a això afegim els 18,6 milions de contactes telefònics, tenim 28 milions de contactes no presencials, en comparació als 24,7 milions de contactes presencials. El resultat és que les tecnologies de la comunicació van ajudar a resoldre el 53% dels contactes i van contribuir moltíssim a resoldre problemes de salut durant la pandèmia. Altres països de l'OCDE van fer una proporció inferior de teleconsultes, vegeu el gràfic de l'informe de l'OCDE:

El missatge és que la tecnologia ajuda però també complica les coses si no som capaços de gestionar-la. Ens cal donar una resposta acurada amb una nova organització de les tasques. Ara que tant es parla de la càrrega burocràtica dels metges, caldria donar-hi resposta precisament mitjançant una nova organització de les tasques, on precisament la tecnologia de la informació hi té molt a dir. Posar a l'abast l'accés a les  tecnologies de la informació en medicina sense modificar l'organització és motiu de desajust assegurat. 

Més enllà de la millora en l'accés a l'assistència que aporten les TIC, i per tant una major quantitat de contactes no presencials, caldria també comprendre quin és el valor que aporten, i per tant com contribueixen a una major eficiència. Caldria doncs separar el gra de la palla, allò que realment afegeix valor a la salut en l'assistència no presencial d'allò que és superflu i ens ho podríem estalviar i alhora suposa una càrrega evitable. I d'aquesta manera aclarir quina part tenen les TIC de substitutives o si són simplement additives. D'això en sabem poca cosa, només aquí en trobareu un exemple encertat. Ara ens en falten molts més exemples en temps fora de pandèmia.

PD. Avui toca llegir FT també. Big pharma groups rejoin battle with governments on drug prices. Si no hi teniu accés me'l podeu demanar per correu electrònic.

El missatge: 

When European health authorities head to the negotiating table, they will have to come to terms with a drug industry that is no longer focused on producing daily pills to pop.

Whereas drugmakers used to make a little from each patient in a large market, increasingly they are focused on charging more to treat small subsets of patients, with rare diseases, or in oncology, with a certain mutation in their tumour.

Governments have not been giving their health systems more money to cope with this change.

Tot d'una algú s'ha adonat que no hi ha mercat en els medicaments sota patent, sino que tenim un monopsoni. Ha tardat molt, però ha arribat el dia que han conegut el monopsonista que és qui mutualitza el risc poblacional d'emmalaltir. I ara només cal veure com es desenvolupen els escenaris, o captura del regulador/monopsonista o benestar social. 

Pharma, big pharma (17)

 Big Pharma. The Money Behind the Pills

Contents:

Chapter 1

Big Pharma’s New Deal: Acquisition and Little Innovation

Blockbuster Drugs Are So Last Century BY ALEX BERENSON

When Academia Puts Profit Ahead of Wonder BY JANET RAE-DUPREE

Grant System Leads Cancer Researchers to Play It Safe BY GINA KOLATA

Are Doctors Too Wary of Drug Companies? BY PAULINE W. CHEN, M.D.

Valeant’s History of Deal-Making BY WILLIAM ALDEN

Roche to Buy InterMune for $8.3 Billion BY ANDREW POLLACK AND MICHAEL J. DE LA MERCED

Why Are So Few Blockbuster Drugs Invented Today? BY DAN HURLEY

$2.6 Billion to Develop a Drug? New Estimate Makes Questionable Assumptions BY AARON E. CARROLL

Stop Subsidizing Big Pharma BY LLEWELLYN HINKES-JONES

Ways to Fund Research on Rare Diseases THE NEW YORK TIMES

AstraZeneca to Acquire Majority Stake in Acerta Pharma BY CHAD BRAY

Explaining Valeant: The Main Theories BY STEVEN DAVIDOFF SOLOMON

Chapter 2

Monopolies and Exclusivity Drive Price Spikes

Runaway Drug Prices BY THE NEW YORK TIMES

Costly Hepatitis C Drugs for Everyone? BY THE NEW YORK TIMES

New Cholesterol Drugs Are Vastly Overpriced, Analysis Says BY ANDREW POLLACK

Inflated Drug Prices THE NEW YORK TIMES

Drug Goes From $13.50 a Tablet to $750, Overnight BY ANDREW POLLACK

Big Price Increase for Tuberculosis Drug Is Rescinded BY ANDREW POLLACK

Valeant Under Investigation for Its Drug Pricing Practices BY ANDREW POLLACK

Senators Condemn Big Price Increases for Drugs BY ANDREW POLLACK

No Justification for High Drug Prices BY THE NEW YORK TIMES

Another Drug Pricing Ripoff BY THE NEW YORK TIMES

The EpiPen, a Case Study in Health System Dysfunction BY AARON E. CARROLL

The Complex Math Behind Spiraling Prescription Drug Prices BY KATIE THOMAS

The Lesson of EpiPens: Why Drug Prices Spike, Again and Again BY ELISABETH ROSENTHAL

Chapter 3

Disease Branding and the Profusion of Diagnoses

Ritalin Wars BY JUDITH WARNER

Disease Branding BY BEN SCHOTT

Still the ‘Age of Anxiety.’ Or Is It? BY DANIEL SMITH

Ruling Is Victory for Drug Companies in Promoting Medicine for Other Uses BY KATIE THOMAS

A.D.H.D. Seen in 11% of U.S. Children as Diagnoses Rise BY ALAN SCHWARZ AND SARAH COHEN

Is It Really A.D.H.D. or Just Immaturity? BY KJ DELL’ANTONIA

Overselling A.D.H.D.: A New Book Exposes Big Pharma’s Role BY STEVE SILBERMAN

A Profusion of Diagnoses. That’s Good and Bad. BY DHRUV KHULLAR, M.D.

Chapter 4

The Money Behind Epidemics: Preventing, Treating and Healing

For Profit, Industry Seeks Cancer Drugs BY ANDREW POLLACK

F.D.A. Advisory Panel Backs Preventive Use of H.I.V. Drug BY DENISE GRADY

Advocating Pill, U.S. Signals Shift to Prevent AIDS BY DONALD G. MCNEIL JR.

Painkillers Resist Abuse, but Experts Still Worry BY ALAN SCHWARZ

The C.E.O. of H.I.V. BY CHRISTOPHER GLAZEK

The Insanity of Taxpayer-Funded Addiction BY THE NEW YORK TIMES

F.D.A. to Expand Medication-Assisted Therapy for Opioid Addicts BY SHEILA KAPLAN

As Opioid Prescriptions Fall, Prescriptions for Drugs to Treat Addiction Rise BY ABBY GOODNOUGH

Chapter 5

The Trump Administration vs. Big Pharma

The Real Reason Medicare Is a Lousy Drug Negotiator: It Can’t Say No BY MARGOT SANGER-KATZ

The Fight Trump Faces Over Drug Prices BY KATIE THOMAS

Trump Vows to Ease Rules for Drug Makers, but Again Zeros In on Prices BY KATIE THOMAS

Drug Lobbyists’ Battle Cry Over Prices: Blame the Others BY ERIC LIPTON AND KATIE THOMAS

Draft Order on Drug Prices Proposes Easing Regulations BY SHEILA KAPLAN AND KATIE THOMAS

Lower Drug Prices: New Proposals Carry Lots of Promises BY KATIE THOMAS AND REED ABELSON

What Big Pharma Fears Most: A Trump Alliance With Democrats to Cut Drug Prices BY ROBERT PEAR

Trump Proposes to Lower Drug Prices by Basing Them on Other Countries’ Costs BY ROBERT PEAR

The farce of confidential drug prices (3)

 Exploring the consequences of greater price transparency on the dynamics of pharmaceutical markets

The 2018 OECD report Pharmaceutical Innovation and Access to Medicines suggested that increased price transparency could promote public accountability, while potentially delivering efficiencies to health systems by including economic considerations in coverage, treatment decisions and budget allocation. Despite this, precisely what should be made more transparent, and how greater transparency would affect the functioning of markets, have been poorly characterised. To help frame the policy debate, the OECD undertook an exploration of the potential consequences of greater price transparency on market dynamics. The work included a roundtable and a series of semi-structured interviews, with participation by 19 experts in pharmaceutical pricing, economics of pharmaceutical markets, competition, and law. With an extensive review of the current practice and relevant literature as a preface, this report presents the key findings from those consultations.

 

Efficient health insurance as a first best

 Sick Insurance: Adverse Selection and Regulation of Health Insurance Markets

When heterogeneity in consumer tastes and needs, and in cost and quality of products, are publically observable, markets can price, sort, and match these variations, and product choices made by consumers yield demand signals that foster efficient resource allocation. These conditions hold, roughly, for a broad swath of economic activity, allowing lightly regulated private markets to successfully approximate allocative efficiency. However, in health care systems around the globe today, participants do not necessarily see the big picture of lifetime health costs and quality of life, and in many systems the incentives that consumers and providers face do not promote efficient allocation of health care resources. Information asymmetries are the fundamental source of difficulties in health insurance markets and in efficient provision of health services. Additional factors contributing to poor performance of health markets include (1) government regulation that is intended to protect the disadvantaged and promote equity, but creates incentives antagonistic to allocative efficiency, (2) inefficient provider organizations and non-competitive conduct, sometimes sheltered by government policies, and (3) behavioral shortcomings of consumers in promoting their own self-interest, including inconsistent beliefs regarding low-probability future events, myopia, and inconsistent risk assessment.

The seminal contributions to economic analysis of Kenneth Arrow, George Akerlof, Joe Stiglitz, Mike Spence, Mike Rothschild, and John Riley establish that when there are information asymmetries between buyers and sellers, adverse selection, moral hazard, and counter-party risk can result, causing markets to operate inefficiently or unravel. Asymmetric information between buyers and sellers, or market regulations that restrict competitive underwriting and force common prices for disparate products, can induce adverse selection. Moral hazard occurs when effort to avoid risks cannot be observed by sellers and stipulated in insurance contracts, and buyers have less incentive for risk-reducing effort when some of their potential losses are covered. When the productivity and cost of medical interventions is not known to all parties, then buyers and third-party-payers may not make informed decisions on therapies. Counter-party risk occurs when sellers evade payment of benefits for losses, or fail as agents to respect the interests of the consumers who are their principals. Adverse selection of buyers with high latent risk or low risk-reducing effort, or sellers with high counter-party risk, make insurance less attractive to buyers, and may cause insurance markets to unravel. Administrative overhead will induce less than full insurance. By itself, this does not make insurance market outcomes inefficient, but increasing returns to scale in administrative costs may lead to an inefficient concentrated market.

In principle, the problems of asymmetric information can be overcome by government operation or regulation of health services; in practice, there remains a major mechanism design problem of designing incentives that handle the asymmetries; e.g., “single payer” systems permit additional levers of control, but information asymmetries cause principal-agent problems even in command organizations. Legal mandates and regulations can make adverse selection worse. Government policy on private health insurance markets often reflects a social ethic that individuals should not be denied health care because of inability to pay, expressed for example in requirements that hospitals admit uninsured patients with life-threatening conditions, and a social ethic that insurance contract underwriting should not be based on risk factors such as gender, race, and pre-existing conditions. When these requirements are not publically financed, they are implicit taxes on insurers and providers that are at least in part passed through to consumers as higher premiums that increase the effective load for low-risk consumers. Both the higher loads and the prospect of public assistance as a last resort reduce the incentive for consumers to buy insurance and to pay (or copay) for preventative care.

The United States has, more than any other developed country, relied on private markets for health insurance and health care delivery. These markets have performed poorly. Denials and cancellations, exclusion of pre-existing conditions, and actuarially unattractive premiums have left many Americans with no insurance or financially risky gaps in coverage. Administrative costs for health insurance in the United States are seven times the OECD average. These are symptoms of adverse selection. Delayed and inconsistent preventative and chronic care, arguably induced by incomplete coverage, have had substantial health consequences: the United States ranks 25th among nations in the survival rate from age 15 to age 60. This impacts the population of workers and young parents whose loss is a substantial cost to families and to the economy. If the U.S. could raise its survival rate for this group to that of Switzerland, a country that has mandatory standardized coverage offered by private insurers, this would prevent more than 190,000 deaths per year.

Given the damage that information asymmetries can inflict on private market allocation mechanisms, the obvious next question is what regulatory mechanisms can be used to blunt or eliminate these problems. This involves examining closely the action of adverse selection and moral hazard, and the tools from principal-agent theory and from regulatory theory that can blunt these actions. There is an extensive literature relevant to this analysis that can be focused on the regulatory design question. Less well investigated are the impacts of consumer behavior, particularly mistaken beliefs. This paper examines these issues, and studies the impacts of regulations intended to promote equity and efficiency. More practically, this paper investigates these issues with reference to the private market in the United States for prescription drug coverage for seniors, introduced in 2006 and subsidized and regulated as part of Medicare.

The efficient regulatory design is mandatory universal insurance, this is the answer. But it has to be eficient, otherwise appears duplicate insurance, paying twice for the same. This is the worst second best, a combined failure of mandatory and private coverage.

Pharma industry regulation: extracting or creating value

 The Global Pharmaceutical Industry. The Demise and the Path to Recovery

The pharmaceutical industry has reached a tipping point. Its business growth is predicated upon fagrantly raising drug prices (especially in the U.S.), thereby increasing the inability of patients to afford medications. The clinical trials that provide the basis for pharma’s new drug development rely on biased designs to favor approvable outcomes, even as sponsors selectively publish mainly the reports that contain favorable results for their test drugs. The industry’s research process exerts a corrupting infuence on medical researchers and the channels of medical communication, while its everyday product promotions involve regular payments of financial and other inducements to prescribers that effectively constitute bribes. Even its involvement in continuing medical education poses a confict of interest and a corrupting infuence on medical practitioners.

If pharma continues operating in this manner, it cannot complain when citizens worldwide demand their governments impose onerous restrictions. Each passing week sees the emergence of additional outrages that make such controls more likely.

Any generalization doesn't fit with an objective observation of reality. However, in chapter 5, you'll find proposals for a new regulation.  

Bidencare

 Which Way Will Biden Go on Health Care?

David Cutler says in JAMA:

The biggest choice for the Biden administration and Congressional Democrats is whether to continue with the Affordable Care Act (ACA) or start the transition to a single-payer system. Continuing with the ACA would involve making the recently enhanced subsidies in the ACA’s marketplaces permanent, enacting a public insurance option, providing stronger incentives for Medicaid expansion in recalcitrant states, and pushing for targeted savings in drug prices and administrative costs. A transition to a single-payer system would begin by lowering the age of eligibility for Medicare to 60 years or perhaps 55 years, possibly expanding benefits in areas such as vision, hearing, and dental care, and allowing Medicare to negotiate with drug companies. These 2 approaches are not incompatible; however, it is unlikely that there will be enough money for both.

Clear message to whom it may concern.

 Hockney

The low marginal benefit of ultra-expensive drugs

 Assessing the Added Therapeutic Benefit of Ultra-Expensive Drugs

In US:

The number of ultra-expensive drugs and Medicare beneficiaries taking these drugs has grown significantly, resulting in a very high concentration of Medicare Part D spending on ultraexpensive drugs. Between 73% and 85% of these drugs assessed in France, Canada, or Germany received a low added  therapeutic benefit rating. Policy reforms to address drug prices in the United States should consider developing an assessment framework for added therapeutic benefit to incentivize and reward the development of drugs that offer a significant clinical improvement over the current standard of care. In the interim, use of international assessments would be possible.

However, it may seem weird to our eyes, but:

 Medicare Part D in particular has a problem with ultra-expensive drugs, since it pays nearly 80% of the cost of these drugs, and by law Medicare cannot directly negotiate the price for these drugs with the drug companies

Public funding without the possibility to set the contract for low marginal benefit drugs! The result:

Medicare Part D spending on brand-name drugs for these ultra-expensive drugs increased from 1.5% in 2012 to 19% in 2018

The answer is change the law and set benefits package according to added value. 

Helen Clockburn collection MOMA

Pharma, Big Pharma (2)

 Government, Big Pharma, and The People. A Century of Dis-Ease

A book to read, with this Table of Contents:

Dedication
Acknowledgements
Preface
Chapter One – Introductions
Health
Woman as a Biological and Social Entity
A Different Paradigm
Health Care and Rights
Drugs and Their Role in Society
Drug Policy
Big Pharma
Drug-Related Problems
The People
What’s Ahead
Conclusion
Chapter Two – The Four "P’s"
Introduction
Marketing as an Actualizing Process
The Marketing Mix/The Four "P’s"
Government and the Four "P’s"
Conclusion
Chapter Three – Investigators and Investigations
Introduction
The Hearings
The Grand Inquisitor
Gaylord Nelson – Son of Torquemada
The Fountain Hearings
Senator Kennedy Joins the Fray
Small Business Problems – Dingell
Drug Efficacy Problems – Fountain
Moss on Drug Abuse
Fountain Redux
Congressman Rogers on Transition
Senator Humphrey and the Literature
A Newcomer – Congressman Van Deerlin
Senator Fountain – "One More Time"
Senator Kennedy Returns
FDA Under the Microscope Again
Kennedy – Not Too Tranquil
Gore on Pharmaceutical R & D
Senator Fountain Again
Claude Pepper for the Old Folks
Zomax in the Spotlight
A Pryor Engatement
The Task Force on Prescription Drugs
Research Findings and Recommendations
Conclusion
Chapter Four – Legislators and Legislation
Introduction
Laws and Policy
Bills and Sponsors
The Process
Conclusion
Chapter Five – Regulators and Regulations
Introduction
The Food and Drug Administration
Other Regulators and Regulations
Federal Trade Commission
Federal Communications Commission
Drug Enforcement Administration
Centers for Medicare and Medicaid Services
Patents and Trademarks
State Regulations
Drug Names
Conclusion
Chapter Six – Non-Government Influence
Introduction
Self-Regulation
Third Parties – Managed Care Controls
Formularies and Prescription Limitations
Lawyers
Advocates and Adversaries
Mail Order Pharmacy
Pharmacy Benefit Managers and Outcomes Management
Conclusion
Chapter Seven – The People and Their Drugs
Introduction
The People as Patients
Health Belief Model
Case – Health Belief Model
Attitudes and Evaluation of Drugs
The Sickness Career
The Sick Role
The Sick Role in Acute and Chronic Illness
Compliance with Medication Regimens
Other Influences on Medication Use
What to Do
Death or Maybe Not
Conclusion
Chapter Eight – Response of Big Pharma
Introduction
Response to Government
Big Pharma Speaks
Response of Big Pharma to the People
Some Ideas for Big Pharma
PMA Monographs
Statesmanship
Conclusion
Chapter Nine – Little Pharma and Friends
Introduction
Generic Pharma – Not So Little
Big Bio
What is Special about Specialty Drugs?
Little Boutiques
Back to the Future – Compounding Pharmacists
Friends
Conclusion
Chapter Ten – Greedy Big Pharma
Introduction
Two Parts of Greedy
AARP and Greedy Big Pharma
Congress and Greedy Big Pharma
Risk vs. Reward
Greedy Big Tech
Conclusion
Chapter Eleven – Whence the Drugs?
Introduction
Origins of Drugs
Drug Product Development
Marketing in the Last Century
Invention, Discovery, Development
Curiosities and Surprises
Recommended Reading
Conclusion
Chapter Twelve – Drugs of the Future
Introduction
But Seriously
Drugs in an Aging Society
Future Drugs for the Aged
Lifestyle Drugs
Conclusion
Chapter Thirteen – The Non-Prescription Products Market-Dr. W. Steven Pray
Introduction
Patent Medicines
Laws That Regulated Non-Prescription Products
FDA’s Review of O-T-C Products
The Prescription to O-T-C Switch
A Third Class of Drugs
Quackery – Lacking Proof of Efficacy
Quackery – New Names Confer False Respectability
Conclusion
Chapter Fourteen – Issues and Studies in Pharmacoeconomics
Introduction
The Emergence of Pharmacoeconomic Research
The Cost of Illness
Quality of Life Assessment
The Economics of Non-Compliance
Economic Epidemiology
Conclusion
Chapter Fifteen – On Drug Prices – Dr. E. M. "Mick" Kolassa
Pricing: The Forgotten "P"
The Growing Importance of Pharmaceutical Prices
Prices, Politics and Problems
Pricing Terminology
What is a Pharmaceutical Price?
Price Decision Making
The Value of Pharmaceuticals
The Future of Pharmaceutical Pricing
Chapter Sixteen – Summary, Ruminations and Apologia
Introduction
Ruminations
Trends
What If’s
Apologia

Health Reform Zombies

 Better Now. SIX BIG IDEAS TO IMPROVE HEALTH CARE FOR ALL CANADIANS

Morris Barer and Bob Evans first coined the term “health care zombies” in 1998. A health care zombie is a terrible idea about health care that refuses to die. No matter how many times you drive an evidence-based stake through its heart, it rises from the (un)dead to confront you in the newspapers of the nation, ruining a perfectly good morning cup of coffee.

These ideas have often been proposed as solutions to the pressures on our health care system. But they’ve all been shown, time and time again, to weaken health care quality and sustainability. They also undermine our shared values.

These words sound familiar in our context. However it comes from a canadian book.

A canadian physician reflects her views in a well written book about the health reform. It says:

When care is necessary to improve health, every Canadian deserves reasonable access to it. That means solutions to wait times that help everyone, not just people who can afford to pay for their care. And it means finally bringing medicines under medicare. Across the country, people like Ahmed the taxi driver are forced to sacrifice their long-term health because of the short-term crunch of prescription drug costs. Alongside that profound inequity lives the uncomfortable truth that we pay some of the highest prices in the world for our prescription medicines. Only our governments can take the necessary steps to establish a national pharmacare program that would ensure access, safety, and appropriate use of medicines at a cost that is affordable not just for governments, but also for citizens and for employers.

It is quite incredible that canadians don't have drugs in the benefits package. And this is the outline of the book:

THE BASICS

Dr. Martin Goes to Washington

Getting Our Facts Straight

Taking the Pulse of the System

Health Care Zombies

BIG IDEA 1 Abida: The Return to Relationships

Primary Care: When It Works, It Works

Three Relationships for Health

Rewarding What Matters

BIG IDEA 2 Ahmed: A Nation with a Drug Problem

Medicare’s Unfinished Business

The Price Is Wrong

Prescribing Smarter

BIG IDEA 3 Sam: Don’t Just Do Something, Stand There

The Compulsion to Cure

Slow Medicine

BIG IDEA 4 Susan: Doing More with Less

The Revolving Door of Health Care

What Better Looks Like

The F-Word

BIG IDEA 5 Leslie: Basic Income for Basic Health

Sick with Poverty

Curing Income Deficiency

BIG IDEA 6 Jonah: The Anatomy of Change

From Pilot Project to System Solution

Data: The Brain of the System

The Heart of the Matter

Feet to Do the Walking

CONCLUSION Worthy Action

 

Are Pharmaceutical Companies Earning Too Much?

Are Pharmaceutical Companies Earning Too Much?

Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018

The debate about pharmaceutical companies earnings is a never ending story. Now you can find in JAMA an article that reflects the cost of a new drug: $1336 million. This is the summary:

The FDA approved 355 new drugs and biologics over the study period. Research and development expenditures were available for 63 (18%) products, developed by 47 different companies. After accounting for the costs of failed trials, the median capitalized research and development investment to bring a new drug to market was estimated at $985.3 million (95% CI, $683.6 million-$1228.9 million), and the mean investment was estimated at $1335.9 million (95% CI, $1042.5 million-$1637.5 million) in the base case analysis. Median estimates by therapeutic area (for areas with ≥5 drugs) ranged from $765.9 million (95% CI, $323.0 million-$1473.5 million) for nervous system agents to $2771.6 million (95% CI, $2051.8 million-$5366.2 million) for antineoplastic and immunomodulating agents.

Why this new figure is relevant? Because previous estimates said that it was the more than the double!

The mean estimate of $1.3 billion in the present study was lower than the $2.8 billion (in 2018 US dollars) reported by DiMasi et al,

And   my impression is that we have entered in a difficult world to estimate the real cost. Right now many firms are buying research (buying firms that have already a product close to be commercialised) and they are paying a premium for outsourcing research. Therefore, how to estimate the cost in this situations? Uncertain.

David Cutler asks about the earnings of pharma firms and says:

Ledley showed that from 2000 to 2018, the median net income margin in the pharmaceutical industry was 13.8% annually, compared with 7.7% in the S&P 500  sample. This difference was statistically significant, even with controls, although earnings seemed to be declining over time.

Is this positive return differential evidence of too high a return? Not necessarily. The economics of pharmaceuticals are important to consider. Like several other industries (eg, software and motion picture production), the pharmaceutical industry has very high fixed cost and very low marginal cost. It takes substantial investment to discover a drug or develop a complex computer code, but the cost of producing an extra pill or allowing an extra download is minimal. The way that firms recoup these fixed costs is by charging above cost for the product once it is made. If these upfront costs are not accounted for, the return on the marketed good will look very high.

 Paying more than a drug is worth clinically is not a good strategy. Even if a drug is worth a high price socially, pricing patients who need the drug out of the market is a real loss, even if it leads to more innovation in the future. In still another case, price increases for older, generic drugs serve no innovation purpose. But, as a general rule, it is important to be wary of blunt “lower all drug prices” policies.

Cutler doesn't say too much on price according value and about public funding of research. It leaves the initial question open and waiting for adhoc answers. That's it , it's a complicated issue, no general prescriptions, they need to be adjusted to specific conditions without a captured regulator. This last point is the most difficult one to overcome.

Prix Pictet

Confidential drug pricing without confidential prices

Performance-based managed entry agreements for new medicines in OECD countries and EU member states: How they work and possible improvements going forward

In this blog I've explained my position against confidential prices for drugs. However, there is an option to complicate it: confidential entry agreements. This is the current trend for high cost drugs with uncertain outcome. The report of the OECD explains the current situation in different countries and helps to shed light in this important issue. Just take this short statement and you'll be convinced of the complete mess:

It is difficult to assess to what extent performance-based MEAs have so far been successful. Few countries have formally evaluated their experience. Confidentiality of agreements continues to be a barrier to independent evaluation and little evidence is public. However, information available from expert interviews and from prior studies indicates that CED agreements have so far had a poor track record of reducing uncertainty around the performance of medicines. As a result, some countries have recently reformed CED schemes and some are discontinuing CED agreements altogether in favour of alternatives. The latter include restricted or conditional coverage without a MEA, whereby coverage is initially restricted to certain indications or patient groups and only broadened if and when additional evidence becomes available. Payment-by-result agreements continue to be used quite widely, but they do not always generate evidence
on product performance because data used for triggering payments are not always  aggregated and analysed.

Sophia Al-Maria at Tate