Last Week in Review: 6/28/2021 – 7/2/2021

COVID

CureVac has announced that its COVID-19 vaccine was shown to have an overall efficacy rate of 48% in a Phase 2b/3 trial, when assessed across any severity across all age groups and 15 variants of the disease. Despite the overall efficacy coming in at under 50%, the shot showed an efficacy of 53% against disease of any severity in participants aged 18 to 60 and an efficacy of 77% against moderate and severe disease in participants in the same age range.

Clover Biopharmaceuticals has teamed up with Dynavax Technologies in a commercial supply agreement of the latter’s CpG 1018TM advanced adjuvant, for use in Clover’s protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum).

Policy

Health Canada has once again decided to delay the implementation of the Patented Medicine Prices Review Board (PMPRB) regulatory reforms due to the COVID-19 Pandemic, after they were scheduled to take effect July 1, 2021. This is the third time their implementation has been stalled—it was pushed back to January 1, 2021 from July 1, 2020, then to this July, and now finally, until January 1, 2022. The final PMPRB Guidelines take aim at all patented medicines and propose a pharmaco-economic value be applied to drugs with high costs/sales to gauge how much improvement they offer over existing therapies.

United States Senator Mike Crapo (R-ID), Ranking Member of the Senate Finance Committee, and Senator Richard Burr (R-NC), Ranking Member of the Senate Health, Education, Labor, and Pensions Committee, have reintroduced S. 3129, the Lower Costs, More Cures Act (LCMCA) aimed at lowering prescription drug prices and boosting transparency in the industry, while simultaneously encouraging the development of new cures and treatments. The bill will take up the mantle of the House’s H.R. 19, which was also first introduced in 2019.

The Association of the British Pharmaceutical Industry (ABPI) has put out a call for six “senior leaders from across the patient charity sector” to join a newly formed Patient Advisory Council. The Council, which will advise the ABPI Board and ensure patient perspectives are embedded in its decision-making process, is part of the group’s new Patient Engagement Strategy which was launched in June 2021.

Access Consortium members the Therapeutic Goods Administration (TGA) of Australia, Health Canada, the Health Sciences Authority (HSA) of Singapore, Swissmedic, and the Medicines and Health Care Products Regulatory Agency (MHRA) of the United Kingdom have published their Strategic Plan 2021-2024, which envisions further alignment on drug regulations and work-sharing to provide faster access to safe, effective, and high-quality medicines.

Pricing & Reimbursement

In its newly revised Evidence Report, the Institute for Clinical and Economic Review (ICER) maintained a health-benefit price benchmark (HBPB) range lower than $10,000 for Aduhelm (aducanumab), despite the company’s already announced $56,000 price tag. In the updated document, ICER finds that the price range needed to reach standard cost-effectiveness thresholds is $3,000-$8,400, representing an 85%-95% discount from Biogen’s announced list price.

Biosimilar

France’s generics and biosimilar manufacturers association (Gemme) has published a list of measures that it believes would help increase uptake of biosimilar drugs in France. According to the association, biosimilars are “an opportunity to ensure the sustainability of our health system,” and as such is campaigning for a “model that provides reassurance for patients and an incentive for healthcare professionals (doctors and pharmacists)” in order to “make it possible to achieve the set objectives” of the National Health Strategy 2018-2022.

HTA

The Netherlands’ National Health Care Institute (Zorginstituut) has advised the Health Minister to include Zejula (niraparib) in the country’s basic healthcare package for a subgroup of patients without a proven BRCAl/2 mutation in ovarian cancer.

The High Health Authority (HAS) is in favor of reimbursement for AbbVie’s Skyrizi (risankizumab) for the treatment of severe chronic forms of plaque psoriasis in adults.

At its 58th council meeting, the Danish Medicines Agency made nine new recommendations and updated four recommendations.

Drug Approval

The Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China has released its 2020 Report on Drug Evaluation in China, providing an overview of drug approvals for the year 2020. A full breakdown of the CDE’s 2020 regulatory activities can be found here.

The European Commission (EC) has approved Sanofi and Regeneron’s Libtayo (cemiplimab) for the treatment of adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted bluebird bio’s LentiGlobin an innovation passport via the new innovative licensing and access pathway (ILAP).

The European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC).