Required PMS case reports reduced for Genvoya and Descovy

In consideration of their reduced sales due to release of follow-on drugs

Unable to reach an agreement on ‘including retrospective investigations as evidence cases for PMS report’

The number of evidence cases reported for post-marketing surveillance of HIV treatments ‘Genvoya tab (emtricitabine / tenofovir alafenamide/ cobicistat / elvitegravir)’ and ‘Descovy tab (emtricitabine / tenofovir alafenamide) that are subject to reevaluation will be adjusted.

 

Genvoya and Descovy, which received marketing authorization from the Ministry of Food and Drug Safety in September 2016 and February 2017, respectively, are up for reexamination by September 12th and have been conducting post-marketing surveillance for 6 years since their release.

 

The PMS cases that were required for the report are 3000 cases for Genvoya and 600 for Descovy, but the Central Pharmaceutical Affairs Council saw consensus on the need for the number of cases to be adjusted to 1,430 and 460 for each.

 

The results were detailed in the minutes of the CPAC meeting disclosed recently by the Ministry of Food and Drug Safety.

 

The committee members have judged that the number of evidence cases reported should be adjusted in consideration of the indications and the reduced sales for Genvoya, and the refunds and characteristics of its indication for Descovy.

 

◆Descovy = In detail, the committee chair of the safety and pharmaceutical reexamination review subcommittee explained that when a new standard-of-care is introduced, the number of new patients taking the drug decreases while the number of HIV-positive patients remains the same, the 600 PMS cases required for Descovy may not be realistic.

 

The MFDS said, “The drug was not designated an orphan drug due to the availability of various alternatives.

 

As setting a fixed number, 3,000 or 600, unilaterally on drugs rose as an issue, the company is allowed to present an appropriate number of evidence cases for the report in the process of determinations, but as the actual market situation may change, the number is often later adjusted according to the market situation.

 

The explanation came after the inquiry on why AIDS treatments do not fall into the category of rare diseases when the number of AIDS patients was 14,000.

 

A committee member said, “The number of PMS cases for submission should be reviewed and applied consistently within the ministry.

 

A standard should be set internally to adjust the number of PMS cases.” Some had raised the opinion that AIDS treatments should be reviewed from a different standard than other general medicines when setting the number of required evidence cases for examinations.

 

Another committee member said, “Due to the small number of patients and short duration of the drugs, it is hard to collect cases according to regulations.

 

The short duration of action of the drug and the number of patients are not being considered.

 

Since the additional investigation period will not help increase the number of collected cases, it would be better to close the re-examination within the set period and sort out the side effects as soon as possible.”

◆Genvoya = Both Descovy and Genvoya are Gilead Science Korea’s products, and the committee members focused on the fact that was the same company has been supplying improved follow-on STR formulation.

 

The committee saw that the fact that the company supplies both the product subject to case number adjustments and follow-on products was an important factor and that the pharmaceutical company is leading the market by focusing on marketing its follow-on drug.

 

The committee members weighted on the fact that the reason why Descovy and Genvoya cannot collect the number of required cases is that the market share has shifted with the release of its follow-on drugs.

 

Another member said, “The follow-on drug will also be subject to reexaminations, and we should require the company to fill the number of evidence cases early on in those subject to the PMS.

 

As the PMS should be conducted in patients who are new users of the drug, the company may apply for another adjustment without the allowance of retrospective studies." To this, some members had suggested that cases in the retrospective studies should also be included as PMS cases for submission.

 

A member said, “There may be distortions in the retrospective survey depending on the patient's memory, but as the collection of results for the retrospective study is based on medical records, there will be no major distortions.

 

We need to accept retrospective study results.” However, the MFDS said, “The PMS is conducted to monitor all adverse events.

 

There is still room for data distortion with retrospective investigations.” The committee was able to reach an agreement on adjusting the number of cases, the members were unable to reach an agreement due to discord on filling the number of cases with retrospective studies.

 

The chair of the committee said, “We ask the MFDS for more thorough supervision of the latecomer drugs developed and prepared by the pharmaceutical companies that developed the originals so that the companies could fully concentrate on PMS in the early stages after release.”