Hyalgan denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage Hyalgan 20 mg/2 mL syringe, once weekly for three weeks. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the patient’s osteoarthritis. The submitted documentation supports the medical necessity of the requested medication regimen. A study conducted a systematic review on the efficacy and safety of repeat courses of hyaluronan therapy in patients with osteoarthritis of the knee and concluded that repeat courses of the hyaluronans were safe and effective in the treatment of pain associated with osteoarthritis of the knee. There is no maximum amount of injections established by high quality scientific evidence. This patient presents with chronic right knee pain and functional limitations in activities of daily living.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Hyalgan or Supartz. Findings: This patient presents with a history of right knee pain due to progressive degenerative changes as demonstrated on magnetic resonance imaging (MRI). Treatment has included an unloader brace, Naproxen, topical diclofenac, Norco, and ibuprofen. The provider has recommended treatment with viscosupplementation with Hyalgan or Supartz injections of the right knee for osteoarthritis. Evidence from systematic reviews and randomized controlled trials indicate that although viscosupplementation may relieve knee pain in some patients with osteoarthritis, data has not established which patients will benefit. Guidelines from the American Academy of Orthopedic Surgeons (AAOS) indicate that the data on safety and efficacy of viscosupplementation remain inconclusive.

Where the denial was upheld

A 60-year-old female enrollee has requested Hyalgan (hyaluronic acid) injections for treatment of her osteoarthritis. Findings: The physician reviewer found that review of this patient’s medical records does not describe a case specific factor which would support the likelihood of a clinical benefit with the requested Hyalgan injections. In addition, the medical literature does not support the efficacy of repeated series of Hyalgan injections. To the contrary, the studies document level II evidence that hyaluronan injections have little to no efficacy in this setting. Well designed double-blinded placebo-controlled studies have not demonstrated a significant positive effect from intra-articular hyaluronan as compared to placebo. In the study conducted by Jorgensen and colleagues, no appreciable improvement was found in patients at 3, 6, 9, and 12 months after injection.

A 57-year-old female enrollee has requested repeat bilateral viscosupplementation (Hyalgan) every 6 months for treatment of her bilateral osteoarthritis of the knees. Findings: The physician reviewer found that the efficacy of Hyalgan as a method of treatment has been supported for several years by level III and level IV studies. Specifically, one study demonstrating the efficacy of viscosupplementation was controlled for selection bias and placebo effect (Jørgensen and colleagues). The researchers randomized 337 patients to a double-blind administration of Hyalgan or saline. The patients were carefully selected to meet the American College of Rheumatology criteria for knee osteoarthritis with a Lequesne algofunctional index score of 10 or greater.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Hyalgan, then check the rights and deadlines that apply to your plan.