To ensure the timely development of vaccines to curb the spread of COVID-19, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) released the principles it will follow in evaluating a vaccine candidate. Developed last month but released Oct. 12, the principles address the various stages of vaccine development from preclinical to post-market and discuss the inclusion of specific populations, such as older people, pregnant women and nursing mothers. The document describes two pathways: one for vaccines first developed for the Japanese market and the other for vaccines initially developed in other countries. The document also discusses manufacturing requirements. Even if a large-scale confirmatory trial is conducted overseas, the PMDA said there may be a “high need of evaluating the efficacy and safety of the vaccine in Japanese subjects,” given the possibility of viral mutations, ethnic differences, and the varying severity of the disease and pandemic by geographic location. Since the demand for a COVID-19 vaccine is expected to be large, vaccines with smaller and fewer doses are preferred. If multiple doses will be needed, “it is preferable to have a shorter dosing interval for rapid acquisition of immunity,” the PMDA said, encouraging sponsors to consider such factors in the early stages of development. To determine safety, the PMDA will require trial sponsors to collect adverse events (AEs) of solicited local and systemic reactions observed during at least the first seven days after administration, as well as all AEs observed during at least the first 28 days after administration. Trials also should assess the risk that a vaccine candidate may worsen the disease. For long-term efficacy and safety, sponsors should follow subjects for at least one year after the trial; however, a longer follow-up may be required depending on the characteristics of the vaccine candidate. During the follow-up, sponsors will be required to collect data about the persistence of antibody titer and the incidence of COVID-19 and AEs, including assessment of the disease enhancement risk. The PMDA doesn’t usually require pharmacokinetic studies for vaccines intended to prevent infectious diseases. But if a SARS-CoV-2 vaccine contains a novel substance, pharmacokinetic studies of that substance may be required, the agency said.

ICER cost models going global

The Institute for Clinical and Economic Review’s (ICER) cost-effectiveness models are going international via a cloud-based platform that allows health technology assessment agencies (HTA) across the world to customize the model assumptions and inputs. ICER’s Interactive Modeler will launch in November for payers, life science companies, patient groups and other stakeholders. The first offering will be the COVID-19 model that ICER developed to evaluate the cost-effectiveness of Gilead Sciences Inc.’s Veklury (remdesivir) and other COVID-19 therapies. Going forward, ICER will make additional models from previous, ongoing and future cost-effectiveness reports available within the Interactive Modeler. “Because many new drugs are launched first in the U.S., ICER is often the first HTA organization to perform a formal assessment – including independent economic modeling – of a new drug,” ICER President Steven Pearson said. He noted that ICER already has had extensive interest among HTA groups in utilizing its COVID model. Making the cost-effectiveness models available to all international HTAs should improve the transparency of assessments and enable HTAs to inform governmental decisions about drug pricing and coverage with economic model results based on science and tailored to reflect diverse health systems, according to ICER.

Canada prepares for ICH Q12

To give regulators and stakeholders sufficient time to prepare, Health Canada plans to implement the International Conference on Harmonisation’s (ICH) Q12 guidance and annexes on technical and regulatory considerations of pharmaceutical lifestyle management in the third quarter of 2021. ICH Q12 provides a “framework to facilitate the management of post-approval chemistry, manufacturing and controls (CMC) changes in a more predictable and efficient manner across the product lifecycle,” according to Health Canada. The guideline is expected “to promote innovation and continual improvement in the biopharmaceutical sector and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments,” the Canadian agency said. Health Canada will launch a stakeholder consultation early next year to get feedback on the final elements of implementing the guidance in Canada.

HHS partners on Lyme innovation

The U.S. Department of Health and Human Services (HHS) and the Steven & Alexandra Cohen Foundation announced the Lymex Innovation Accelerator, a $25 million public-private partnership aimed at advancing treatments for Lyme and other tickborne diseases by collaborating directly with Lyme patients, patient advocates, and stakeholders in academia, nonprofits, industry and government. Unveiled Oct. 10, the partnership will include up to $25 million for Lyme innovation and competition prize awards, with diagnostics prize challenges a big priority, HHS said. The first Lymex diagnostics prize is to be launched next year. Open to U.S. universities, nonprofits, companies and domestic organizations, the challenge will focus on improving diagnostics at all stages of Lyme disease.

AMA adds codes for COVID-influenza testing

The American Medical Association (AMA) said it has added several new codes and code revisions for reporting services related to the COVID-19 pandemic, two of which are multi-analyte assays for both the SARS-CoV-2 virus and one or more strains of influenza. CPT code 87636 is a new category I code for detection of nucleic acids for the SARS-CoV-2 virus and types A and B influenza using a multiplex amplified probe technique, while CPT 87637 is identical, but with the addition of syncytial virus. The editorial panel also revised CPT codes 87301-87430 by deleting the term “multi-step method” from descriptors, which the AMA said clarifies the proper reporting for antigen tests that are read by machines. A new category I code, 87811, reports infectious agent antigens picked up by immunoassay and detected by direct visual observation. AMA President Susan Bailey said the multi-analyte codes should help to “conserve important testing resources, allowing for ongoing surveillance of influenza while testing for the novel coronavirus.”

MedPAC concerned about post-pandemic telehealth

In comments to the docket for the draft Medicare physician fee schedule (MPFS) for calendar year 2021, the Medicare Payment Advisory Commission (MedPAC) said it is concerned about the continuation of expanded Medicare coverage of telehealth under the pandemic after the public health emergency is over. The U.S. Centers for Medicare & Medicaid Services (CMS) has temporarily expanded coverage of telehealth as a means of tamping down on the spread of COVID-19, but MedPAC said the agency should carefully consider the impact of a permanent expansion of telehealth on “the already challenging fiscal solvency and program integrity of the Medicare program.” The commission said its 2018 report to Congress urged caution in expansion of tele-mental health services because of concerns that the quality of care might be diminished compared to face-to-face services. The American Medical Association (AMA) also sounded off on the draft MPFS, claiming that the draft rule would cut 5.5% from total physician payment after a budget neutrality adjustment designed to offset a new office visit policy. The AMA also urged the CMS to include office visit increases for global surgical payments and supports the relative value update committee’s recommendation that post-operative visits be valued the same as stand-alone office visits. Contrary to the position staked out by MedPAC, the AMA recommended that make permanent several telehealth coverage policies rolled out for the pandemic. AMA President Susan Bailey said physicians have “made unique sacrifices during the pandemic,” adding that the coverage flexibilities added to account for the pandemic must stay in place “as COVID is still presenting challenges every day.”

CMS: CLIA audits yield cease-and-desist letters

The U.S. Centers for Medicare & Medicaid Services (CMS) said it is taking action to ensure that clinical labs in the U.S. are providing accurate and reliable test results for the COVID-19 pandemic by reviewing lab certifications to ensure those certifications are current. The agency said a recent check of records for certification under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 resulted in the issuance of more than 170 cease-and-desist letters to labs that lacked current CLIA certification. The CMS said it had provided an expedited CLIA certification process early in the pandemic to streamline the process along with a quick-start guide to ease a lab’s certification burden. Roughly one-third of the 171 cease-and-desist letters issued since Aug. 12, were for labs that lacked a certificate while the remainder were for labs that were practicing tests outside the scope of certification.

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