Does health technology assessment compromise access to pharmaceuticals?

Büssgen, Melanie; Stargardt, Tom

doi:10.1007/s10198-022-01484-4

Cited by 8 publications

(7 citation statements)

References 39 publications

(37 reference statements)

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“…[38][39][40] The core data elements include product name, manufacturer, pack form, strength, and size. MIDAS sales data have been widely used to investigate sales, prices, and launches across countries 5,[22][23][24][25][26]28,41,42 and by PMPRB in their annual reports, 2 Meds Entry Watch reports, 43,44 existing guidelines, 45 and research webinars related to their proposed guidelines. 32,46,47…”

Section: Data Sourcementioning

confidence: 99%

“…[21][22][23][24][25][26][27] However, few studies have investigated the impact of price changes or expected price changes within a single country. [28][29][30][31] The PMPRB's own assessment in 2020 found "no early signs that patented medicine price reforms are resulting in fewer new medicines being launched in Canada." 32 In contrast, assessments conducted or commissioned by industry groups found or projected reductions in the number of drug launches and delays in drug launches in Canada as a result of the proposed amendments.…”

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confidence: 99%

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The impact of proposed price regulations on new patented medicine launches in Canada: a retrospective cohort study

Zhang,

Sun,

Guh

et al. 2024

CMAJ

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Background:The Patented Medicine Prices Review Board (PMPRB), the agency that regulates the prices of patented medicines in Canada, published proposed amendments to the regulatory framework in December 2017. Because of a series of changes and delays, the revised policy has not yet been finalized. We sought to evaluate the potential early impact of the uncertainty about the PMPRB policy on patented-medicine launches. Methods:We developed a retrospective cohort of patented medicines (molecules) sold in Canada and the 13 countries that the PMPRB currently uses or has proposed to use as price comparators, from sales data from the IQVIA MIDAS database for 2012-2021. The outcome was whether a molecule was launched (i.e., sold) in a specific country within 2 years of its global first launch (2-yr launch). We compared the change of 2-year launch before (2012-2017) and after the proposed amendments were published ("uncertain period," 2018-2021) in Canada with the change in the United States and the other 12 countries as a group ("other-countries group"), using interrupted time series and logistic regressions, respectively. We further conducted analyses for each individual country and subgroups by molecule characteristics, such as therapeutic benefit, separately. Results:We included 242 and 107 new molecules launched before publication of the proposed amendments and during the uncertain period, respectively. The corresponding 2-year launch proportions were 45.0% and 30.8% in Canada, 81.4% and 82.2% in the US, and 83.9% and 70.1% in the other-countries group. All analyses showed changes in 2-year launch during the uncertain period in the US and in the othercountries group that were similar to the changes in Canada. Greater decreases were observed in Norway and Sweden than in Canada. The 2-year launch proportion for molecules with major therapeutic benefit decreased from 45.8% to 31.3% in Canada during the uncertain period and from 87.5% to 62.5% in the other-countries group, but increased from 91.7% to 100% in the US. Interpretation:No negative impact of the PMPRB-policy uncertainty on molecule launches was observed when comparing Canada with price-comparator countries, except for molecules with major therapeutic benefit. The reduction in launches of medicines with major therapeutic benefit in Canada requires continuing investigation.

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Section: Data Sourcementioning

confidence: 99%

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confidence: 99%

The impact of proposed price regulations on new patented medicine launches in Canada: a retrospective cohort study

Zhang,

Sun,

Guh

et al. 2024

CMAJ

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“…Conditional funding models and outcome-based agreements: In some countries such as Germany, new therapies may be made available to patients very rapidly after regulatory approval, prior to completion of an HTA or funding negotiation with the drug's manufacturer [106,107]. Some countries may also negotiate an outcome-based agreement (OBA) with a company [108].…”

Section: Controlling Drug Pricesmentioning

confidence: 99%

“…RWE can then be collected during the period of HTA assessment. This approach is currently taken by Germany and some other countries [106,107].…”

Section: Hazard Ratios and Relative Vs Absolute Gainmentioning

confidence: 99%

New Anticancer Drugs: Reliably Assessing “Value” While Addressing High Prices

Stewart,

Bradford,

Sehdev

et al. 2024

Current Oncology

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Countries face challenges in paying for new drugs. High prices are driven in part by exploding drug development costs, which, in turn, are driven by essential but excessive regulation. Burdensome regulation also delays drug development, and this can translate into thousands of life-years lost. We need system-wide reform that will enable less expensive, faster drug development. The speed with which COVID-19 vaccines and AIDS therapies were developed indicates this is possible if governments prioritize it. Countries also differ in how they value drugs, and generally, those willing to pay more have better, faster access. Canada is used as an example to illustrate how “incremental cost-effectiveness ratios” (ICERs) based on measures such as gains in “quality-adjusted life-years” (QALYs) may be used to determine a drug’s value but are often problematic, imprecise assessments. Generally, ICER/QALY estimates inadequately consider the impact of patient crossover or long post-progression survival, therapy benefits in distinct subpopulations, positive impacts of the therapy on other healthcare or societal costs, how much governments willingly might pay for other things, etc. Furthermore, a QALY value should be higher for a lethal or uncommon disease than for a common, nonlethal disease. Compared to international comparators, Canada is particularly ineffective in initiating public funding for essential new medications. Addressing these disparities demands urgent reform.

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“…Econometrically speaking, the countries to which we compared Germany all had a parallel trend in the pre-policy period. That is, the reductions in launch delay did not differ over time for any of the country comparisons to Germany before AMNOG (Büssgen and Stargardt [ 2 ] figures 1–6 and results from the placebo regressions). Thus, it is not apparent to us why the difference in ‘catching-up’ that we only start to observe after the introduction of AMNOG (and not before) should be interpreted as being unrelated to AMNOG.…”

mentioning

confidence: 99%

Does health technology assessment compromise access to pharmaceuticals?

Büssgen¹,

Stargardt²

2023

Eur J Health Econ

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In response to rapidly rising pharmaceutical costs, many countries have introduced health technology assessment (HTA) as a ‘fourth hurdle’. We evaluated the causal effect of HTA based regulation on access to pharmaceuticals by using the introduction of Germany’s HTA system (AMNOG) in 2011. We obtained launch data on pharmaceuticals for 30 European countries from the IQVIA (formerly IMS) database. Using difference-in-difference models, we estimated the effect of AMNOG on launch delay, the ranking order of launch delays and the availability of pharmaceuticals. We then compared the results for Germany to Austria, Czechia, Italy, Portugal and the UK. Across all six countries, launch delay decreased from the pre-AMNOG period (25.01 months) to the post-AMNOG period (14.34 months). However, the introduction of AMNOG consistently reduced the magnitude of the decrease in launch delay in Germany compared to the comparator countries (staggered DiD: + 4.31 months, p = 0.05). Our logit results indicate that the availability of pharmaceuticals in Germany increased as a result of AMNOG (staggered logit: + 5.78%, p = 0.009). We provide evidence on the trade-off between regulation and access. This can help policymakers make better informed decisions to strike the right balance between cost savings achieved through HTA based regulation and access to pharmaceuticals.

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Does health technology assessment compromise access to pharmaceuticals?

Cited by 8 publications

References 39 publications

The impact of proposed price regulations on new patented medicine launches in Canada: a retrospective cohort study

The impact of proposed price regulations on new patented medicine launches in Canada: a retrospective cohort study

New Anticancer Drugs: Reliably Assessing “Value” While Addressing High Prices

Does health technology assessment compromise access to pharmaceuticals?

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