New Delhi: The US medical device lobby group AdvaMed has said India’s drug pricing regulator’s decision not to raise the prices of knee implants for another year could take a “toll" on manufacturers. The US trade association said it was “critical" for the government to evaluate the long-term “negative impact" of such decisions on patient outcomes.
The National Pharmaceutical Pricing Authority (NPPA) had reduced knee implant prices by as much as 69% last August. The reduced prices were to be effective for a year. This month, while reviewing its decision, the NPPA decided to extend the ceiling price by another year.
The trade association representing nearly 350 medical technology firms, including manufacturers like Abbott Laboratories, Boston Scientific Corp. and Medtronic Inc., had urged the regulator to allow a minimum 10% increase in the price this year.
The US medical lobby group said it had hoped for a better outcome, adding that the government decision has the ability to restrict innovations, and limit patient access to state-of-the-art medical care.
“We hoped for a better outcome that values quality, safety and clinical results and expected an informed decision taken after considering the consultations and deliberations held over the course of time," it said.
Claiming that its request should have been considered against the backdrop of increasing cost pressures from a falling rupee, it said the regulator’s decision could take a toll on companies. “We would like to reiterate that it is critical to evaluate the long-term negative impact of such decisions on patient outcomes, the consequent increase in adverse events, and the subsequent rise in the future healthcare costs," it said.
In the one year since the price cap, the rupee has depreciated over 10% while inflation has pushed up operating costs upward of 6%, said AdvaMed. “The industry had put this up to request to the authority requesting for a 10% minimum increase in prices, which for non-scheduled formulations (knee implants fall under this category) is provisioned for, under DPCO," it said.
NPPA had last year said there are as many as 20 million patients who require arthroplasty—a surgical reconstruction or replacement of a joint—but that only about 100,000 can afford to have one every year.
Citing a World Health Organization report, osteoarthritis is likely to become the world’s fourth leading cause of disability by 2020.
According to orthopaedic surgeons, 90% of the knee implants available in India are imported. Companies that sell knee implants in India include Stryker Corp., Smith & Nephew Plc, Biomet Inc., Zimmer Inc. and Johnson & Johnson.