Persius/hicric huggingface dataset:
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease.
Treatment: Stelara.
The insurer denied: Stelara.
The denial is overturned.

The patient is an adult female with Crohn's ileitis who has tried/failed Xifaxan. The request is for Stelara. Per the appeal, the patient cannot use anti-TNF (tumor necrosis factor) alpha agents such as anti-nuclear antibodies and cannot use methotrexate, as she is of child-bearing age.

The requested Stelara is medically necessary.
Yukawa et al. showed that increases in the titers of IF-ANA (immunofluorescent antinuclear antibody) and dsDNA Ab (double-stranded deoxyribose nucleic acid antibody) after IFX (infliximab) therapy were related to poor clinical response and that high titers of ANA (anti-nuclear antibody) (160) before IFX (infliximab) therapy was also related with poor clinical response (reference 1).

For this reason, anti-TNF (tumor necrosis factor) alpha therapy may not be appropriate.

Stelara (Ustekinumab) was FDA (United States Food and Drug Administration) approved for use in Crohn's disease. The drug was previously FDA (United States Food and Drug Administration) approved for a diagnosis of Psoriasis. Ustekinumab is a humanized immunoglobulin G monoclonal antibody targeting IL (interleukin)-12 and IL (interleukin)-23. They in turn thereby inhibit their receptors on T cells, natural killer cells, and antigen-presenting cells.

In a phase 2a study (Sandborn WJ, Gastroenterology, 2008), it was shown that patients on Ustekinumab had higher response rates (53%) at weeks 4 and 8 compared to patients on placebo (30%). In a phase 2b randomized, double-blind, placebo-controlled trial (Sandborn WJ, NEJM, 2012), patients with moderate-to-severe Crohn's disease who failed prior anti-TNF (tumor necrosis factor) therapy had a significantly greater clinical response to Ustekinumab (39.7%) at week 6 compared to the placebo group (23.5%) (P = .005).

In the NEJM (New England Journal of Medicine) article (Sandborn, 2012), the design of the study included an induction phase (weeks 0-8) followed by a maintenance phase (weeks 8-36). During the induction phase, subjects randomly received 1-time dose of intravenous placebo or ustekinumab at 1, 3, or 6 mg/kg (milligrams per kilogram). During the maintenance phase, subjects were randomized to receive subcutaneous ustekinumab at a dose of 90 mg (milligrams) or placebo at weeks 8 and 16. Subjects who responded to the placebo continued to get the placebo at weeks 8 and 16 and those who did not respond to the initial placebo received subcutaneous ustekinumab at a dose of 270 mg (milligrams) at week 8 and 90 mg (milligrams) at week 16. As stated in the article, "the proportions of patients who reached the primary endpoint were 36.6%, 34.1%, and 39.7% for 1, 3, and 6 mg [milligrams] of ustekinumab per kilogram, respectively, as compared with 23.5% for placebo (P=0.005 for the comparison with the 6-mg [milligram] group)."
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Substance Abuse/Addiction - Alcohol intoxication.
Treatment: Inpatient hospital admission.
The insurer denied the hospital admission. 
The denial is upheld. 

The patient is a male with hypertension (HTN) and depression, who presented to the emergency department (ED) with suicidal ideation and alcohol intoxication; he was initially admitted to inpatient psychiatry but developed increasing confusion, agitation, and an unsteady gait requiring multiple doses of lorazepam. At admission, his temperature was 98, blood pressure (BP) was 124/80, heart rate (HR) was 78, and respiratory rate (RR) was 12. He was disoriented, heart rate was regular, breathing comfortably with clear lungs, and was agitated and confused. He was started on a Clinical Institute Withdrawal Assessment (CIWA) protocol with lorazepam.
By the next day, he was awake, alert, and oriented; he had atypical chest pain, electrocardiogram (ECG) and troponin was unremarkable.
He remained alert, appropriate, cooperative with no confusion or agitation, low CIWA scores, as needed (PRN) lorazepam continued. The plan was for transfer back to inpatient psych.
CIWA scores remained low, and he was felt ready for transfer back to psychiatry whenever a bed was available. 
At issue is the medical necessity of the Hospital Admission.

The health plan's determination of medical necessity is upheld in whole.

No, the requested health service/treatment of Hospital Admission was not medically necessary for this patient.
The patient presented from a psychiatry unit with confusion and agitation for 12 days after being admitted for suicidal ideation and alcohol intoxication. It would be quite unusual to develop acute alcohol withdrawal 12 days after the last drink (usual is at 48-72 hours). Additionally, if this were alcohol withdrawal (or agitation for any other reason), by the day following his medical admission, he was calm, cooperative, and alert and oriented. There were no additional or alternative diagnoses or concerns (drug reaction, seizure, central nervous system (CNS) infection, etc.). As alcohol withdrawal was unlikely this late into the stay and as he normalized within 12-24 hours, an inpatient admission was not medically necessary.  The patient did have atypical chest pain, but this was low risk, unlikely to represent a concerning diagnosis, and acute coronary syndrome was excluded with a normal ECG and labs.
Therefore, the requested health service/treatment of Hospital Admission is not medically necessary.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Migraines
Treatment: Qulipta 60 mg (milligrams) tablet
The insurer denied the Quilipta 60 mg tablet.
The determination is upheld.

The patient is a female with a history of migraines. She was prescribed the drug Qulipta for treatment. The drug was denied because the patient has not tried and failed Ajovy, Aimovig, and Emgality. The provider appealed the determination.

At issue is the coverage for the non-formulary drug, Qulipta.

The health plan's determination is upheld in whole.

There is no reason that Ajovy, Emgality, or Aimovig would not be effective for prevention of migraine. There is no documentation that the patient has previously tried and failed these medications. Ajovy, Aimovig, and Emgality are Food and Drug Administration (FDA) approved for prevention of episodic and chronic migraine. These medications have been shown to decrease migraine frequency by approximately 50 percent (%). There is no comparative data available to suggest that Qulipta is more effective than Ajovy, Aimovig, or Emgality.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Psoriatic Arthritis
Treatment: Enbrel
The insurer denied the Enbrel.
The determination is upheld.

The patient has psoriatic arthritis. Enbrel was denied by the health plan; the reason for the denial is 'the documentation does not support the dx of active psoriatic arthritis (PsA) ' and as per the health plan's criteria the patient has not had past treatment (tx) with disease modifying anti-rheumatic drug (DMARD) 's (e.g. methotrexate (MTX)) and there is no prior trial/failure/contraindication to the preferred biologics (e.g. Humira, Skyrizi, Stelara, Tremfya, Cosentyx, Cimzia). Upon review of the medical records, the patient was diagnosed with PsA based on dactylitis of the left foot as well as sausage digit of the left index finger. She also had psoriasfiorm lesions along the scalp and periauricular areas of the ears. She has been on Enbrel 50 milligrams (mg) weekly with good response. She was advised to reduce the dose to every 2 weeks. At issue is whether Enbrel is medically necessary.

The requested health service/treatment of Enbrel is not medically necessary for this patient. 

There is no medical reason she cannot try one of the preferred therapies on the health plan's formulary. The treatment of psoriatic arthritis (PsA) includes MTX and biologics. According to UpToDate, 'in patients whose joint counts do not improve substantially after three months of treatment with a conventional nonbiologic disease modifying anti-rheumatic drug (DMARD) (eg, MTX) or who still have more than three tender and swollen joints, we recommend a tumor necrosis factor (TNF) inhibitor' and 'the efficacy of the TNF inhibitors in patients with PsA has been well-documented in meta-analyses involving several of the agents'. Moreover, in patients who do not respond adequately to two different TNF inhibitors, the standard of care includes interleukin (IL)-17 inhibitors (e.g. Cosentyx) or the interleukin (IL)-12/23 inhibitor (Stelara). The agents on the health plan's formulary (e.g. Humira, Skyrizi, Stelara, Tremfya, Cosentyx, Cimzia) are consistent with the standard of care in the treatment of PsA.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic Dermatitis (AD). 
Treatment: Dupixent 300 mg (milligrams)/2 ml (milliliters) SC (subcutaneous) SOPN (solution pen injector). 

The insurer denied coverage for Dupixent 300 mg/2 ml SC SOPN. 

The denial is overturned. 

This is a patient with a diagnosis of atopic dermatitis. The condition is severe, affecting >20% (percent) TBSA (total body surface area). The patient has failed therapy with tacrolimus ointment, topical steroids, and methotrexate. The patient was previously successfully treated with Dupixent for over one year with excellent clinical response and no documented adverse events. The requested medication is Dupixent. 

The patient has severe atopic dermatitis that involve a large surface area. The patient requires systemic therapy given the extent of involvement and the use of Dupixent would appear to be reasonable given that it is FDA (Food and Drug Administration) approved for the treatment of atopic dermatitis and the therapeutic failure with methotrexate, tacrolimus, and topical steroids. The request for Dupixent is supported by the medical literature and specialty society guidelines. Dupixent is the only systemic therapy approved by the FDA for the management of atopic dermatitis.  The FDA approved Dupixent for adults with moderate-to-severe AD who are inadequately controlled with topical treatments (1-3). According to consensus guidelines "Dupilumab has shown strong efficacy and safety for treatment of moderate-to-severe AD.  Considering the safety profiles of conventional systemic therapies, which are not FDA-approved for AD treatment, it is recommended that dupilumab be used as a first-line systemic treatment with moderate-to-severe AD who are uncontrolled with topical therapies" (1). As such, the decision is reversed and Dupixent is approved based on the standard of care. 

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Dupixent 300 mg/2 ml SC SOPN services is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cancer - Lymphoblastic leukemia.
Treatment: Sprycel 100mg tablet.

The insurer denied Sprycel 100mg tablet.  The denial is upheld. 

This is a male patient with presenting history of night sweats and lymphadenopathy. He underwent diagnostic evaluation with bone marrow aspiration/biopsy and lymph-node biopsy. He has diagnosis of Myeloid/lymphoid neoplasms with eosinophilia, clinically T-cell acute lymphoblastic leukemia (T-cell ALL) with platelet-derived growth factor receptor alpha (PDGFRa) rearrangement with cysteine rich hydrophobic domain 2 (CHIC2) gene deletion (PDGFRa (4q12), 1GRA 1GA) and clonal T-cell receptor gene arrangement. Negative cytogenetics and normal next generation sequencing (NGS). Patient is receiving Hyper Cytoxan, vincristine, doxorubicin, dexamethasone (CVAD) chemotherapy regimen. Treating physician is requesting treatment with dasatinib (Sprycel).

At issue is the medical necessity of Sprycel 100 milligrams (mg) tablet (dasatinib) number (#) 30/30 days.

The health plan's determination is upheld in whole.

The requested health service/treatment of Sprycel 100mg tablet (dasatinib) #30/30 days is not medically necessary for this patient.

Sprycel (Dasatinib) is not a recommended treatment for Philadelphia chromosome-like (Ph-ve) acute lymphocytic leukemia (ALL) or for treatment of Myeloid/lymphoid neoplasms with eosinophilia. There are many published reports/case series showing efficacy of Imatinib in this setting, but not dasatinib. Dasatinib is recommended for treatment for Philadelphia chromosome Ph (BCR-ABL) positive acute lymphoblastic leukemia. It is not recommended by the National Comprehensive Cancer Network (NCCN) for treatment of Ph-ve ALL. No published case reports to show efficacy of dasatinib in treatment of Myeloid/lymphoid neoplasm with eosinophilia (particularly without ABL 1 rearrangement).

Therefore, the requested health service/treatment of Sprycel 100mg tablet (dasatinib) #30/30 days is not medically necessary.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Hypogonadism
Treatment: Testosterone 1.62% gel
The insurer denied the Testosterone 1.62% gel.
The determination is upheld.


The patient has a history of hypogonadism on testosterone replacement therapy. The appeal documentation states that the patient has been stable on this formulation. Documentation states that life may be in jeopardy related to this medication which is non-formulary drug. An appeal is requested. He is on testosterone 1.62% (40.5/2.5) packets, 2 packets topically every day.
The formulary alternative(s) are testosterone transdermal gel 25 milligrams (mg) /2.5 grams (g) (1%); testosterone transdermal gel 10 milligrams per actuation (mg/act) (2%); testosterone cypionate; testosterone enanthate. Requirement: 3 in a class with 3 or more alternatives, 2 in a class with 2 alternatives, or 1 in a class with only 1 alternative.
At issue is whether the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects.

No. This reviewer is not aware of any data to support that the testosterone 1.62% 40.5/2.5 packets would be more effective or have less adverse effects than any of the formulary alternatives (testosterone transdermal gel 25 mg/2.5 g (1%); testosterone transdermal gel 10 mg/act (2%); testosterone cypionate; testosterone enanthate). According to Ullah et al, transdermal testosterone delivery indications, adverse effects, and contraindications are fairly similar. (1) As such, there is not a strong clinical indication that the patient cannot be switched to one of the transdermal testosterone replacement options.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Thyroid Eye Disease
Treatment: Tepezza
The insurer denied: Tepezza
The denial is upheld.

The patient is a male with refractory thyroid eye disease (TED). He has been treated with ablative iodine x 2 and undergone a full series of Tepezza infusions over the course of 43 months of active disease. Most recently, he was treated with high dose oral prednisone with good response of his ocular motility. His recent clinical activity score (CAS) was 10. Given the active phase of the disease, he is recommended to undergo another round of Tepezza (teprotumumab) injections. This has been rejected by his insurance company as experimental. He is appealing this decision.

The health plan's determination is upheld.

The requested Tepezza is not likely to be more beneficial than standard treatment.
Thyroid eye disease (TED) is an autoimmune disease caused by the activation of orbital fibroblasts by autoantibodies directed against thyroid receptors. TED is a rare disease, which had an incidence rate of approximately 19 in 100,000 people per year in one study. The disorder characterized by enlargement of the extraocular muscles, fatty and connective tissue volume. this patient has ongoing active TED. The traditional therapies used in this stage of the disease include high dose oral prednisone or orbital radiation to reduce the inflammation in the orbit. Rituximab has also been used to reduce orbital inflammation in patients with thyroid eye disease. The OPTIC X study evaluated the safety and efficacy of teprotumumab treatment and re-treatment in patients from the double-masked OPTIC study. This has allowed a more complete understanding of outcomes associated with (1) patients with longer disease duration, (2) re-treatment efficacy in initial nonresponders or those who experience disease flare, and (3) additional safety evaluations in these populations. Most patients re-treated with teprotumumab showed clinically significant reductions in proptosis and diplopia, although the number of patients was small (11/14 retreated patients had a reduction in proptosis). The authors of this study acknowledge that this reduction in retreated patients needs to be confirmed by further study. Therefore, it cannot be said that Tepezza in more likely to be beneficial than prednisone, orbital radiation or steroid sparing biologics.
There is early evidence that retreatment may be beneficial in some patients, but it is still experimental. It is not likely that Tepezza will be more beneficial than standard treatments.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Thyroid Eye Disease
Treatment: Tepezza
The insurer denied: Tepezza
The denial is overturned.

The patient is a male with chronic thyroid eye disease with high triiodothyronine (T3) and thyroxine (T4) levels who is seeking treatment with Tepezza. This was denied by the plan on the basis that it is experimental in this case. The patient has a history of primary open angle glaucoma. He is on Combigan and Latanoprost. Records indicate that the patient has severe active disease. He has a Clinical Activity Score of 10. The patient was on a course of Prednisone a few months prior to presentation, which did not help. He was also on Solumedrol for a flair. He had a course of Tepezza previously which he responded well to. The subject under review is whether Tepezza treatment is likely to be more beneficial for this patient than any standard treatment for his thyroid eye disease. 

Treatment with Tepezza is likely to be more beneficial than any standard treatment for this patient's thyroid eye disease.
Tepezza has been shown to significantly reduce proptosis, inflammation, diplopia, strabismus and orbital soft tissue volume in patients with thyroid eye disease. This patient has active disease with significant inflammatory symptoms, diplopia, lid retraction, and proptosis. As mentioned above the Clinical Activity Score is 10. The patient has significant disease that has been treated with steroid therapy without results. Tepezza may be used to help reduce the need for surgical intervention for the treatment of chronic thyroid eye disease.
Tepezza is a Food and Drug Administration (FDA) approved medication for the treatment of thyroid eye disease. The need for more aggressive treatment including surgical decompression and strabismus surgery may be avoided in those patients receiving Tepezza treatment.
Safety and efficacy of Tepezza is supported in the literature based on clinical studies and is likely to be of greater benefit to this patient than any standard treatment.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Thyroid Eye Disease
Treatment: Tepezza
The insurer denied: Tepezza
The denial is overturned.

The patient is a male with thyroid eye disease for whom coverage of Tepezza is the subject of review. Coverage was previously denied as more than eight doses per lifetime was determined to be experimental/investigational.
An exam documents the patient having severe active phase thyroid eye disease with lid retraction, proptosis, diplopia and significant inflammatory signs/symptoms with a Clinical Activity Score of 10. The patient failed high dose oral steroids a few months prior to presentation and was not a surgical candidate due to the active phase of the disease. The patient had finished a course of Tepezza. Another course of Tepezza was recommended.
An exam documents the patient having thyroid eye disease. It is also noted that the patient tried 80 milligrams (mg) prednisone without help. The patient had also received Solumedrol urgently for a flare within the past week. Ocular history is notable for primary open angle glaucoma for which the patient takes Combigan and latanoprost. Vision was 20/100 both eyes (OU) without improvement on pinhole testing. Intraocular pressures were 12 mmHg OU. Limited elevation and abduction was noted OU. Fullness and retraction of eyelids was noted along with proptosis OU. It is further noted that the patient finished a course of Tepezza. Recent thyroid function testing showed high triiodothyronine (T3) and thyroxine (T4), and the patient's endocrinologist was confident that it could be stabilized medically.  The subject under review is whether the proposed treatment with Tepezza is likely to be more beneficial than any standard treatment for the patient's condition.

There is a growing body of evidence for the efficacy of retreatment with Tepezza in patients with chronic thyroid eye disease (TED) with low clinical activity score (CAS) as well as those experiencing flare following prior Tepezza treatment. The patient failed high dose oral steroids a few months prior to presentation and was not a surgical candidate due to the active phase of the disease. He has responded well to Tepezza in the past. A second course of Tepezza is supported by the peer reviewed medical literature, and is likely to be more beneficial for this patient than any standard treatment.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Back Pain
Treatment: Pain Management (62321x1 - additional pain injection to the spine)
The insurer denied: Pain Management (62321x1 - additional pain injection to the spine)
The denial is overturned

The patient is an adult female with low back and mid back pain. The patient has thoracic paraspinal muscle tenderness and decreased sensation at T9-12 (thoracic nine through twelve) on the left.  The patient is taking Flexeril, ibuprofen, and topical Pennsaid.  Magnetic resonance image (MRI) of the the thoracic spine shows posterior disc herniation at T2-3 (thoracic two through three), T7-8 (thoracic seven through eight) and T8-9 thoracic eight through nine).  The patient had a thoracic epidural steroid injection with 100% relief for six months.  The first thoracic epidural the patient received 80% relief for one year.  The request for repeat thoracic epidural steroid injection was denied.

The proposed treatment is medically necessary.
It generally would not be considered medically reasonable and necessary for treatment with epidural steroid injection (ESI) to extend beyond 12 months. Use beyond twelve months requires the following:
1.  Pain is severe enough to cause a significant degree of functional disability or vocational disability. (Met)
2.  Epidural steroid injection (ESI) provides at least 50% sustained improvement of pain and/or 50% objective improvement in function (using same scale as baseline). (Met)
3.  Rationale for the continuation of epidural steroid injections (ESIs) includes but is not limited to patient is high-risk surgical candidate, the patient does not desire surgery, recurrence of pain in the same location relieved with epidural steroid injections (ESIs) for at least three months. (Met)
4.  The primary care provider must be notified regarding continuation of procedures and prolonged repeat steroid use. (Not applicable)

In this case, the patient has had only one other epidural steroid injection within the last twelve months which provided 100% relief for six months.  The previous epidural steroid injection five years ago provided 80% for one year.  As such, in this case it is reasonable and medically necessary to repeat the epidural steroid injection at this time.