A Medical Device Daily

Digene (Gaithersburg, Maryland) said that as of Jan. 1, French insurer MAAF Sante will pay for HPV DNA testing of all women in that country between the ages of 30 and 65, who are most at risk of developing cervical cancer.

The insurer also will fund HPV DNA testing for women of all ages whose Pap results are inconclusive or as a “test of cure“ for women treated for cervical disease.

Digene said that this will mark the first time in France and the second time in Europe that reimbursement for HPV testing for all uses — including routine, primary screening to identify women at risk of cervical cancer — will be offered by a major insurer.

The Digene HPV Test, which uses the company's Hybrid Capture II (hc2) technology, is the only clinically validated, FDA-approved and CE-marked test for detecting the presence of high-risk types of the human papillomavirus (HPV), the cause of cervical cancer.

“Only the combination of a negative (normal) Pap and a negative HPV test can provide a full guarantee that the risk of developing cervical cancer within the next three years is equal to zero,“ MAAF Sante said in announcing its new policy.

A similar decision was reported in January by Deutsche BKK, a major public-health insurance provider in the central Wolfsburg region of Germany, in partnership with the local gynecologists' association and a regional hospital.

“This announcement in France — coming after a parallel decision by a major insurer in Germany earlier this year — is an important milestone for cervical cancer screening and prevention programs globally, and should trigger similar shifts in the standard of care elsewhere in France, Europe and around the world,“ said Rob Lilley, senior vice president, global sales and marketing at Digene.

The first HPV vaccine was approved recently by the FDA for girls and young women age 9-26, but Digene said screening will continue to be important, since the vaccine protects against just two types of the virus responsible for 70% of cervical cancers, and has only been shown to be effective in women not yet exposed to the targeted types of HPV.

Report cites recommendations for trials

A group established to make recommendations on improving the safety of Phase I clinical trials in the UK has published its final report. The independent Expert Scientific Group (ESG) was convened by the Secretary of State for Health to examine trials involving new types of drugs, following adverse reactions experienced by participants in the clinical trial of the drug known as TGN1412 earlier this year.

The ESG made 22 recommendations, which are expected to have far-reaching implications for those involved in the conduct and safety of first-in-man clinical trials.

The recommendations cover a number of key areas, including:

  • The need for scientific advice from independent experts before trials of high-risk substances are approved.
  • Information about unpublished clinical trials and adverse reactions occurring in trials.
  • The conduct and environment of clinical trials.
  • The clinical trial application process.
  • The skills and future specialist training needs of those conducting clinical trials.
  • The location of trial units and the provision of adequate medical backup in case of problems arising.

Professor Gordon Duff, chairman of the ESG, cited “the alarming outcome of the TGN1412 trial“ and said, “There is certainly a need to develop new medicines for conditions where current treatment is inadequate but, in clinical trials, the well-being of volunteers must always come first. We believe our recommendations would safeguard this in the future.“

Health Minister Andy Burnham said, “We believe that implementing the wide-ranging and comprehensive recommendations made in this report could make a significant contribution to improving the safety of clinical trials of high-risk drugs such as TGN1412. We will be studying them carefully.“

The scientific group met a wide range of stakeholders and considered many written submissions sent to it, including results of scientific tests from the National Institute for Biological Standards and Control , which may provide potential answers to scientific questions surrounding the adverse reactions to TGN1412.

The Medicines and Healthcare products Regulatory Agency (MHRA) already has implemented recommendations introducing precautionary measures in the approval and conduct of trials in the UK on an interim basis. Those interim arrangements will remain in place until they are replaced by European guidance.

The MHRA also has put in place procedures for accessing independent scientific advice, and an expert advisory group that will review applications for trials of high-risk substances will be established next year.

Recognizing the need for better communication between the main organizations responsible for approval of clinical trials, the MHRA and the UK Ethics Committee Authority jointly published a memorandum of understanding on Oct. 30 setting out details on information sharing between MHRA and research ethics committees.

Burnham said some of the expert group's recommendations, such as those proposing greater sharing of information about trials and adverse reactions, have far-reaching implications. He said the government would discuss with relevant stakeholders, including the pharmaceutical industry and academia, how best to ensure that the necessary changes are implemented.