The High Court has ruled that the National Institute for Health and Clinical Excellence (NICE) must look again at its decision not to fund the use of osteoporosis drug Protelos on the NHS.
The drug’s manufacturer, Servier Laboratories, challenged NICE’s decision through a judicial review, as the drug company believed guidance issued by the NHS financial watchdog unfairly restricted Prostelos’ use.
The High Court ruled that by not releasing the economic model used to make its decision, NICE acted unlawfully. This follows a ruling in 2008 ordering NICE to release the economic model used in assessing Alzheimer’s medicines. The court ordered NICE to allow stakeholders such as patient organisations, clinicians, industry and professional associations access to its economic model. NICE may be required to re-evaluate its guidance.
The current guidance from the watchdog states that osteoporosis patients who are unable to tolerate the recommended initial treatment should wait until their bone mineral density (BMD) deteriorates before they are given an alternative treatment.
Commenting on the ruling, Dr Tim Spector, consultant rheumatologist at St Thomas’ Hospital said: “This is a great result for osteoporosis patients. Many of my patients are unable to tolerate the treatment recommended by NICE under the current guidance but I have to wait for their disease to deteriorate before I can give them an alternative treatment. This would leave them unprotected from the risk of fracture for many years.”
Dr Spector said that he hopes the opportunity to review the guidance and economic assumptions made by NICE will lead to simpler and more flexible guidance, and allow clinicians a greater choice in the prescribing decisions they make for their patients.