Bipolar disorder (BPD) is a chronic illness characterized by recurrent episodes of aberrant mood, and treatment must be tailored to each patient’s current disease stage (i.e., acute manic episode, acute depressive episode, or maintenance phase). Historically, mood stabilizers such as lithium and antiepileptic drugs (AEDs) were the mainstay of treatment; at present, atypical antipsychotics also play a large role owing to their regulatory approval for bipolar depression and bipolar mania and as maintenance therapies. Within the atypical antipsychotic drug class, Bristol-Myers Squibb/Otsuka’s Abilify (aripiprazole) and quetiapine (AstraZeneca’s Seroquel, generics) continue to dominate BPD treatment; among newly diagnosed patients, Abilify and quetiapine are almost tied for first-line patient share. Thought leaders consider Abilify to have a lower propensity to cause weight gain and metabolic side effects compared with quetiapine and olanzapine (Eli Lilly’s Zyprexa, generics) but also believe it is less effective than quetiapine and olanzapine for certain phases of treatment. Quetiapine’s approval for treatment of both poles of BPD—mania and depression—sets this agent apart from other atypical antipsychotics and has helped make it a key market leader in this drug class. Emerging atypical antipsychotics such as lurasidone (Sumitomo Dainippon Pharma/Sunovion/Takeda’s Latuda) will compete in a crowded and genericized market. It is not enough for emerging agents to offer a better weight-gain profile over current agents; they must also demonstrate efficacy for more than just the treatment of mania to make an impact on the market.

This report uses national patient-level claims data to explore the position of the leading maintenance therapies in the treatment of newly diagnosed bipolar disorder patients with a quantitative analysis of treatment patterns and share by line of therapy, as well as progression between lines, duration of treatment on each line, and use of concomitant treatment. The report also quantifies a drug’s source of business among recently treated bipolar disorder patients compared with its competitors and details which drugs precede others through an analysis of add-versus-switch patterns. Additional analyses explore persistency and compliance by brand.

Questions Answered in This Report:

  • Newly diagnosed patients: Treatment of BPD depends upon the phase of the illness that the patient is experiencing: acute manic episode, acute depressive episode, or long-term maintenance. Typically, newly diagnosed patients are experiencing a depressive episode when they present to a healthcare provider; unsurprisingly, therapies that physicians prefer for bipolar depression dominate early-line therapy. What drugs and drug classes compete for first-line patient share in newly diagnosed BPD patients? What are the dynamics of branded agents, such as Seroquel XR (AstraZeneca) and Abilify, across early lines of therapy?

  • Recently treated patients: AEDs and selective serotonin reuptake inhibitors (SSRIs) are generally considered safer and more tolerable than atypical antipsychotics, but because of their relatively greater efficacy in treating BPD symptoms such as mania, antipsychotics are often added to existing treatment regimens in later lines. Lamotrigine, quetiapine, and Abilify are among the most commonly used drugs for BPD, according to our recently treated patient analysis. How do the pathways to each drug in BPD differ? How do the differentiating features of each branded drug influence the progression to that drug within the key analysis period? How long does it take a patient to move through a preceding therapy before he or she adds quetiapine or Abilify?

  • Pathways to key therapies: Longitudinal claims data reveal that lamotrigine is the leading agent in first-, second-, and third-line therapy for BPD; these data also detail which agents in a given class compete with lamotrigine. Which drugs precede the use of lamotrigine? Which drugs are used most often in combination with lamotrigine? How much is Abilify competing with quetiapine for second- and third-line space? Which drug(s) precede the use of Latuda, one of the up-and-coming therapies in the BPD space following its U.S. approval for bipolar depression?

Scope:

Primary patient-level data: This report provides quantitative findings from our analysis of data covering approximately 40 million lives and provides the most representative sample of U.S. treatment practice for Medicare and commercially insured patients. This report is delivered as a key findings slide deck and a dashboard that can be accessed using the internet with claims that are less than six months old at the time of publication.

Patient Sample:Patients aged 18 or older who are continuously enrolled for the complete two-year study period must meet the following condition: at least one claim with a diagnosis code for BPD (International Classification of Diseases, Ninth Revision [ICD-9] diagnostic codes (296.0, 296.1, 296.4, 296.5, 296.6, 296.7, 296.80, and 296.89) during the study period.

Quantified lines of therapy analyses show exact share of each agent in each line of therapy, including rate of progression between lines and length of time patients are on each line.

Newly Diagnosed Patients:

- Patient share by drug class and key products across three lines of therapy, within one year of diagnosis.

- Patient flowcharts through one year of treatment for all first-line products, including progression rates and add/switch behavior.

- Polypharmacy and key concomitant therapies by line of therapy.

- Quarterly trending of patient share by line of therapy.

Recently Treated Patients:

- Quarterly snapshot of patient share by drug class and key products.

- Pathway to key therapy flowcharts tracking the preceding therapy patterns for all key therapies, including add/switch behavior.

- Brand source of business, including share for continuing, new (switches/adds), and new (initial therapy) business.

- Polypharmacy and key concomitant therapies.

- Drug persistence and compliance.

- Quarterly trends in patient share for all key therapies.


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