STATE OF MICHIGAN
DEPARTMENT OF INSURANCE AND FINANCIAL SERVICES
Before the Director of the Department of Insurance and Financial Services
In the matter of:
Petitioner
v File No. 217819-001
Alliance Health and Life Insurance Company
Respondent
__________________________________________
Issued and entered
this 26
th
day of September 2023
by Sarah Wohlford
Special Deputy Director
ORDER
I. PROCEDURAL BACKGROUND
On August 3, 2023, , authorized representative of (Petitioner), filed
with the Director of the Department of Insurance and Financial Services a request for an external review
under the Patient’s Right to Independent Review Act, MCL 550.1901 et seq. The request for review
concerns a denial for a prescription drug.
The Petitioner receives health care benefits through Alliance Health and Life Insurance Company
(AHL/HAP). The benefits are described in AHL’s Preferred Provider Organization Group Health Insurance
Policy (the policy). The Director notified HAP of the external review request and asked for the information
used to make its final adverse determination. HAP responded on August 10, 2023. The Director accepted
the request on April 10, 2023.
The Director assigned an independent review organization to analyze the medical issues in this
appeal. The review organization submitted its report to the Director on September 18, 2023.
II. FACTUAL BACKGROUND
The Petitioner has polyarthralgia. The Petitioner’s physician recommended adalimumab 40 mg/0.4
mL injection syringe every 14 days and asked HAP to authorize coverage. HAP denied the request on the
basis the criteria of its medical policy were not met.
The Petitioner appealed HAP’s claim processing decision through its internal grievance process. At
File No. 217819-001
Page 2
the conclusion of that process, HAP issued a final adverse determination dated July 31, 2023, affirming its
decision. The Petitioner now seeks the Director’s review of that determination.
III. ANALYSIS
Petitioner’s Argument
In the request for external review, the Petitioner’s physician wrote:
[The Petitioner] is a -year-old woman with polyarthalgia since 3/2021, when she
developed episodes of gradually worsening joint pain/swelling involving her hands,
elbows, shoulders, knees, ankles bilaterally. She experienced intermittent flares as
well as ongoing pain. She has been managing symptoms with ibuprofen with some
relief. She sought medical advice at an urgent care center during a flare and was
prescribed steroid injection that helped. A Medrol dose pack was also very
effective for 3 weeks. Currently her pain prevents work. She also reports increased
fatigue. Clinical features, labs, and x-rays indicative of seropositive non-erosive
Rheumatoid Arthritis (RA). Due to significantly active disease during patient's
office visit I recommended a Medrol pack and to stay on 4mg methylprednisolone
after completion. For DMARD therapy, due to concern of hepatotoxicity from
significant alcohol, use I would like to start Anti-TNF (Humira).
***
The denial also states: "alcohol use, as a reason for not using helpful medications
(i.e. methotrexate), does not demonstrate medical necessity for coverage of
Humira as a criteria exception because alcohol consumption is a modifiable risk
factor and alcohol use can be stopped if therapy for rheumatoid arthritis is
desired."
[The Petitioner] has significant alcohol use and is not able to stop. Also, her
significant intake amount would place her at a substantial risk for alcohol
withdrawal syndrome. Due to her risk for hepatoxicity we cannot use methotrexate,
leflunomide or sulfasalazine. All three of these medications have the potential for
liver toxicity and should be avoided with her alcohol dependence. Her arthritis
symptoms are also severe, and her disease is highly seropositive delaying
therapies will place her at risk for irreversible joint damage. [The Petitioner’s] CCP
is also highly elevated. Elevated CCP has been shown to be predictive of more
aggressive radiographic progression in RA1•2 making hydroxychloroquine
inappropriate as a treatment. Hydroxychloroquine (Plaquenil) will not prevent
erosions. Sulfasalazine is also not appropriate for [the Petitioner] regardless of the
potential for liver toxicity, because of her CCP+ RA, as sulfasalazine would not
prevent erosions either. With her seropositive, CCP+ RA, the first line treatment
would be methotrexate or leflunomide, which she cannot take due to the risk of
liver toxicity. A TNF inhibitor, such as adalimumab is the next most appropriate
medication that is a more potent chronic therapy that will help prevent erosions.
File No. 217819-001
Page 3
Adalimumab (Humira) is an FDA approved TNF-alpha immunomodulator that has
proven efficacy.
Treatment options for [the Petitioner] are limited due to her coexistent liver
disease. Her rheumatology team have carefully considered treatment options and
believe Humira is the best choice for her. Considering the increase in severity of
disease for [the Petitioner] I believe she will benefit greatly from a medication that
will prevent joint damage. We urge you to reconsider approval of Humira. Thank
you for your consideration.
Respondent’s Argument
In its final adverse determination, HAP wrote:
HAP's Benefit Administration Manual (BAM) Policy titled Anti-Inflammatory
Biologics for the Treatment of Rheumatoid Conditions outlines Coverage Criteria,
Limitations and Exclusions for use of Humira for the treatment of rheumatoid
(relating to the joints) medical conditions such as rheumatoid arthritis
(inflammation affecting the joints), spondyloarthropathies [inflammatory arthritis
affecting the spine and large joints; categorized as axial (spine) or peripheral
(lower limbs, hips)], juvenile idiopathic arthritis (JIA) and more.
The provider requested Humira for management of rheumatoid arthritis.
Specifically, per HAP Criteria for use of Humira, in rheumatoid arthritis,
documentation must show trial and failure (after 3 months, medication was not
helpful) to the following:
Triple-Therapy - Triple-therapy includes disease modifying medications (DMARDs
- medications to help manage inflammation related to your condition) of
methotrexate (25mg week), hydroxychloroquine (200mg twice daily), and
sulfasalazine (1000 mg twice daily). [If side effects occur with methotrexate,
leflunomide may be substituted for methotrexate.]
Information provided indicates the member has not tried/taken triple-therapy due
to her current alcohol use. Please note alcohol use, as a reason for not using
helpful medications (i.e., methotrexate), does not demonstrate medical necessity
for coverage of Humira as a criteria exception because alcohol consumption is a
modifiable risk factor and alcohol use can be stopped if therapy for rheumatoid
arthritis if desired. Additionally, based on the member’s most recent laboratory
results, the member’s liver function tests are within normal range and do not
indicate liver disease at this time.
The provider’s appeal letter indicates that the member has elevated CCP (anti-
cyclic citrullinated peptide antibody) levels which could be predictive of more
aggressive disease progression in rheumatoid arthritis; therefore, preference is to
treat with Humira instead of triple-therapy with DMARDs. However, please note
that current treatment guidelines (i.e., 2021 American College of Rheumatology
Guideline for Treatment of Rheumatoid Arthritis) do not indicate preference for use
File No. 217819-001
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of a biologic medication over triple therapy as initial treatment for patients with
elevated CCP levels.
If a biologic therapy is preferred, HAP provides coverage of infliximab (biosimilar
Inflectra or Renflexis) without prior authorization. Infliximab is an anti-TNF
medication and is similar to Humira. Infliximab doses can be adjusted according to
member symptoms.
Director’s Review
The Director assigned an independent review organization (IRO) to evaluate HAP criteria and help
determine whether the adalimumab 40 mg/0.4 mL is medically necessary for treating the Petitioner’s
condition. This review is required by section 11(7) of the Patient's Right to Independent Review Act, MCL
550.1911(7).
The IRO reviewer is a physician who is board-certified in rheumatology. The IRO reviewer’s report
included the following analysis and recommendation:
1. Does the Claimant meet HAP’s criteria for the drug Humira?
No.
2. Are these criteria the standard of care for this drug?
Yes.
3. If not the standard of care, is this drug medically necessary per standard of
care?
No.
Based on the Claimant's history of alcohol use, a trial of the conventional synthetic
disease-modifying antirheumatic drugs (DMARD) leflunomide would be
reasonable prior to considering biologic therapy. Leflunomide has demonstrated
efficacy in treating rheumatoid arthritis, with less gastrointestinal side effects
compared to methotrexate. A starting dose of 10mg daily, titrated up to 20mg daily
within 4 weeks if tolerated, could be tried for at least 12 weeks to determine
treatment response. Liver function will be monitored due to alcohol use. If the
Claimant does not exhibit improvement in joint symptoms after adequate
leflunomide dose optimization, transitioning to a TNF inhibitor biologic could be the
next step per rheumatoid arthritis guidelines.
Later, given this Claimant’s lack of response to other DMARDs, a biologic may
ultimately be needed to control disease activity.
Based upon the above observations, the ACR has published guidelines for
monitoring DMARD-induced hepatotoxicity in patients with rheumatoid arthritis. It
should be noted, however, that these recommendations are based upon expert
opinion. In general agreement with these guidelines, we recommend the following:
File No. 217819-001
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• Medical history – Patients should be periodically questioned about adherence to
avoiding intake of alcoholic beverages, any intercurrent medical issues, and to
confirm proper self-administration of their leflunomide once daily. Regarding
alcohol use, it is best if the clinician has a repeated dialogue with the patient
regarding the extent of alcohol consumption, particularly if new elevations of
transaminase enzymes are detected while on chronic leflunomide therapy.
• Routine blood testing – Blood sampling for measurement of aminotransferases,
albumin, and complete blood count should be obtained at four- to eight-week
intervals initially. Monitoring can be extended to every 12 weeks after 6 months of
stable therapy.
• Indications for more frequent blood tests:
• Use of other hepatotoxic medications – Patients on leflunomide who are also
taking methotrexate, sulfasalazine, etc. should be monitored more closely, such as
monthly.
• Elevated body mass index with abnormal tests – Obese patients (BMI ≥30) with
elevated liver enzymes at baseline should be monitored monthly to check for
progression to NASH while on leflunomide therapy. The dose may need to be
lowered or the drug discontinued if abnormalities persist.
This approach aims to regularly assess liver function and hematologic parameters
through routine monitoring, with increased vigilance in higher risk patients or those
on concurrent hepatotoxic medications. It is important to counsel all patients about
avoiding excessive alcohol intake as well.
The IRO reviewer recommended that the Director uphold HAP’s denial of coverage.
The Director is not required to accept the IRO’s recommendation. Ross v Blue Care Network of
Michigan, 480 Mich 153 (2008). However, the recommendation is afforded deference by the Director. In a
decision to uphold or reverse an adverse determination, the Director must cite “the principal reason or
reasons why the director did not follow the assigned independent review organization’s recommendation.”
MCL 550.1911(18)(b). The IRO’s review is based on extensive experience, expertise, and professional
judgment. In addition, the IRO’s recommendation is not contrary to any provision of the Petitioner’s
certificate of coverage. MCL 550.1911(17).
The Director, discerning no reason why the IRO’s recommendation should be rejected in the
present case, finds that adalimumab 40 mg/0.4 mL (Humira) is not medically necessary and is, therefore,
not covered under the Petitioner’s benefit plan.
IV. ORDER
The Director upholds Alliance Health and Life Insurance Company’s July 31, 2023, final adverse
determination.
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Page 6
This is a final decision of an administrative agency. Under MCL 550.1915, any person aggrieved by
this order may seek judicial review no later than 60 days from the date of this order in the circuit court for
the Michigan county where the covered person resides or in the circuit court of Ingham County. A copy of
the petition for judicial review should be sent to the Department of Insurance and Financial Services, Office
of Research, Rules, and Appeals, Post Office Box 30220, Lansing, MI 48909-7720.
Anita G. Fox
Director
For the Director:
Recoverable Signature
X
Sarah Wohlford
Special Deputy Director
Signed by: Sarah Wohlford
