Early access for innovative oncology medicines: a different story in each nation

Cowling, Tara; Nayakarathna, Ransi; Wills, Allison; Tankala, Dipti; Roc, Nancy Paul; Barakat, Stéphane

doi:10.1080/13696998.2023.2237336

Cited by 3 publications

(3 citation statements)

References 21 publications

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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%

“…HTA approaches in Canada: A description of some of the problems associated with HTA approaches in Canada may inform other jurisdictions. Unlike Germany, England and Wales, France, Italy and Australia, Canada does not have a mechanism to permit publiclyfunded early access to innovative oncology therapies prior to HTA assessment [107]. Compounding this is the problem that the HTA process for drugs in Canada is uniquely long and complex [109].…”

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%

See 2 more Smart Citations

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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Section: Controlling Drug Pricesmentioning

confidence: 99%

Section: Controlling Drug Pricesmentioning

confidence: 99%