U.K. Viagra Reimbursement Extended To All Prostate Cancer Patients

The U.K.' s National Health Service proposed regulations covering reimbursement for Pfizer's Viagra and other erectile dysfunction therapies have been expanded to include all patients being treated for prostate cancer, the Department of Health reported in a May 7 statement.

The U.K. DoH "has decided to extend the list of eligible conditions to encompass all men treated for prostate cancer (not just those who have had a prostatectomy as originally proposed)."

The Department of Health had initially recommended that Viagra and other therapies be restricted to patients who had undergone prostatectomy or radical pelvic surgery and patients with spinal cord injury, diabetes, multiple sclerosis or single gene neurological disease ("The Pink Sheet" Jan. 25, p. 18).

In addition to prostate cancer patients, the U.K. government's final decision regarding reimbursement for erectile dysfunction treatments has added renal failure patients receiving transplant or dialysis, and patients with poliomyelitis, spina bifida, or Parkinson's disease.

The Department of Health has additionally decided that general practitioners may be reimbursed for prescriptions of impotence treatments to men who do not fall within the specified patient populations, "but who were receiving drug treatment for impotence from the GP on 14 September 1998." The European Commission cleared Viagra for marketing on Sept. 14 ("The Pink Sheet" Sept. 21, 1998, p. 19).

"Men who do not fall into the above categories [may] receive private prescriptions from their GP," the DoH noted. However, "GPs will not be able to charge for writing such prescriptions." The DoH noted that "with the exception of Sweden, Viagra is not generally available in European Union countries at the expense of their healthcare systems."

The amended NHS regulations are slated to go into effect on July 1, following Parliamentary approval. Products affected by the new policy include Viagra, Fournier's Erecnos (moxisylyte) and several alprostadil-containing products: Pharmacia & Upjohn's Caverject, Vivus/Astra's Muse and Schwarz Pharma's Edex/Viridal.

DoH emphasized that the final regulations were developed following a review of the 861 responses received to the proposed regulations.

DoH particularly highlighted the careful consideration given to responses from "the manufacturers of the products affected" and the British Medical Association. The BMA's General Practitioners Committee had urged physicians to disobey the proposed prescription restrictions ("The Pink Sheet" Feb. 8, p. 21).

U.K. Secretary of State for Health Frank Dobson reported that three-quarters of the responses to the proposed regs "supported the idea that prescribing of Viagra by GPs should be restricted - indeed, some 10% thought that it should be banned altogether."

"There was widespread support for some restrictions on prescribing, though much less support for the particular restrictions proposed," DoH acknowledged.

"No alternative solutions were proposed, however, which would be consistent with the objective of containing expenditure to approximately the present level, as not to divert resources from other health conditions and treatments," DoH continued.

The current level of NHS expenditure on erectile dysfunction is close to $17 mil., with an estimated 2 mil. men experiencing impotence in the U.K. Pfizer negotiated an NHS price for Viagra of approximately $8 (L4.84). The price per pill on a private prescription is close to three times the NHS amount.

"It is fair to say that a lot of people thought that more men than I proposed should be eligible for NHS prescriptions for impotence," Dobson commented. "But I have to think of the impact on the NHS as a whole in deciding this."

The final regulations also retain the provision that impotence therapy be provided only once a week. DoH noted that the provision "was widely considered to be reasonable and supported by research evidence that the average frequency of sexual intercourse in the 40-60 age range is once a week." Further guidance on frequency of prescribing will be provided, DoH said.

The new erectile dysfunction policy will be reviewed after one year, DoH reported.