The National Pharmaceutical Pricing Authority (NPPA) on Wednesday fixed the price for primary knee replacement of titanium alloy at Rs 38,740 while the price for revision knee replacement of any material was pegged at Rs 62,770.
The notification comes after the union cabinet decided at a meeting in New Delhi earlier in the day to go for price ceiling of knee implants as many patients who required to undergo the procedure were unable to afford it due to the exorbitant price.
The NPPA notification, which specified the price ceiling, fixed the price for Hi-Flex primary knee replacement at Rs 25,860 and that of cobalt chromium alloy at Rs 24,090.
The prices for other primary knee replacement surgeries of femoral component, such as oxidised zirconium, has also been fixed at Rs 38,740 by the pharma sector price regulator.
"It is noticed that orthopaedic knee implants are having unjustified, unreasonable and irrational high trade margins leading to their exorbitant prices, which affects the out-of-pocket expenses of patients and lakhs of patients are not able to pay for arthoplasty procedures due to exorbitant prices," said the NPPA notification.
According to Arthritis and Sports Medicine Clinic, a total knee replacement prosthesis has four components:
- Femoral component (made of metal), which is fixed to the cut surface of the femur (thigh bone);
- Tibial component (made of metallic tray), which is fixed on the cut surface of the tibia (leg bone);
- Polyethylene liner (made of plastic), which is interposed between the femoral and tibial component and acts as an articulation; and
- Patellar component (made of plastic), which is fixed on the cut surface of the patella (knee cap).
These components are usually fixed to bone using bone cement (polymethyl methacrylate).
Noting that osteoarthritis is likely to become fourth leading cause of disability by 2020, the price control body said: "The estimated patients who require knee replacement surgeries, both diagnosed and undiagnosed, is about 1.5 to 2 crore, out of which only about 1 lakh-plus well-off patients are in a position to pay for it every year."
According to the NPPA, the prices capped for primary knee replacement for tibial component or tibial tray made of titanium alloy and oxidised zirconium has been fixed at Rs 24,280.
For other tibial component of cobalt chromium has been fixed at Rs 16,990, while the price for articulating surface and patella of any material has been fixed at Rs 9,550 and Rs 4,090, respectively.
"The price for primary knee replacement system of tibial tray and insert combined as single unit of polythylene or crosslinked polythylene or highly crosslinked polythylene has been fixed at Rs 12,960, while the prices for similar component of metallic will be fixed at Rs 26,546," said the notification.
As for the revision knee replacement system, femoral component of any material will be Rs 62,770, while the prices for similar surgery of tibial component of any material will be capped at Rs 31,220.
A revision procedure is typically more complex than the original knee replacement surgery, because the surgeon must remove the original implant, which would have grown into the existing bone. In addition, once the surgeon removes the prosthesis, there is less bone remaining.
The NPPA said all manufacturers would comply and implement the ceiling prices mentioned under the applicable category and serial number irrespective of being cementable, uncementable, gender-specific or unisex.
"The manufacturers of uncemented implants, however, may approach NPPA with supporting documents, for fixation of separate ceiling price or retail price," said the NPPA notification, adding that all manufacturers may add goods and services tax and no other charges in the calculations of MRP.