Drug Ad Oth Oral denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Zepbound.In this case, the patient has a history of hyperlipidemia, insulin resistance, and obesity. The patient’s provider has recommended treatment with Zepbound. The U.S. Food and Drug Administration (FDA) approved tirzepatide (Zepbound) for weight management in patients with obesity defined as a BMI of 30 kg/m2 or greater, or overweight with a BMI of 27 kg/m2 or greater, and at least one comorbidity related to being overweight. The Surmount-1 trial was a phase 3, multicenter, double-blinded, placebo-controlled trial assessing over 2,500 patients with obesity or who were overweight with one or more weight-related comorbidities who were prescribed different dosages of Zepbound or placebo.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for intravenous immunoglobulin (IVIG), GammaPLEX every four weeks. Idiopathic nodular panniculitis is a rare disease characterized by the inflammation of adipose tissue. Due to the rarity of this disorder, there are few randomized controlled trials to guide treatment. However, available medical literature, primarily case reports, supports the use of IVIG for cases of refractory idiopathic nodular panniculitis that fail to respond to standard immunosuppressive therapies. Per the medical records, the patient has idiopathic nodular panniculitis and has unsuccessfully utilized several appropriate standard treatment options and failed several immunosuppressive agents over a four-year period.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Journavx. Suzetrigine (Journavx) is U.S. Food and Drug Administration (FDA)-approved for moderate-to-severe acute pain in adults, and the official prescribing information states that its use for acute pain has not been studied beyond 14 days. Therefore, for the indication being requested here, ongoing treatment of chronic ankle pain, chronic low back pain, and persistent shoulder/neck pain, continued use is not supported by the same level of evidence that underpins its FDA-approved, time-limited acute-pain indication. Evidence for chronic/peripheral neuropathic pain remains uncertain.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for ketamine intravenous (IV). In this case, the patient reports pain level primarily involving bilateral scapulae, middle and lower back, hips, and glutes. Treatment trials have included physical therapy, psychotherapy, transcutaneous electrical nerve stimulation (TENS), trigger point injections, and multiple medications. The patient is currently treated with oral ketamine and ketamine infusions. Per the medical literature, the available evidence does not support approval of intravenous ketamine infusion for chronic pain. Collectively, these findings demonstrate insufficient high-quality evidence of durable efficacy and raise safety concerns.

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 drug ad oth oral, then check the rights and deadlines that apply to your plan.