Reducing the burden of treatment intervention

Reducing the burden of treatment intervention

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This section is designed to highlight the points in the treatment of a patient to motherhood, where treatment interventions may need to be made. Here we aim to show the potential burden associated with these interventions from both an NHS and a patient perspective.

We follow the story of a fictional patient called Sandra as she begins planning for motherhood and compare common scenarios with one that may reduce the need to make interventions.

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Sandra's story

Sandra is a 30-year-old full-time hairdresser who suffers from Psoriatic Arthritis (PsA)

She has been on a biologic for over 2 years now and her assessment scores are stable. She does not tolerate methotrexate and so takes her biologic as a monotherapy. Although Sandra suffers from the occasional flare, she manages these at home using paracetamol and ibuprofen when required. This is a long way from where she started when she was diagnosed at the age of 25.

Sandra and her husband have been considering starting a family for some time now. She has been particularly anxious about this as she has been told previously that she cannot take her biologic during pregnancy. Sandra's life prior to starting a biologic was difficult. She did not respond to traditional disease-modifying anti-rheumatic drugs (DMARDs) and the manifestations of the disease massively impacted on her work as a hairdresser.

During times of stress, she would develop bouts of scaly psoriasis on her hands, feet and face. The swelling of her joints in her fingers and wrists made work a struggle and the fatigue was wearing her down.

Sandra's Rheumatologist is aware of her desire to start a family and her treatment plan is discussed in a multidisciplinary team setting. See here for the impact on Sandra of different treatment decisions.

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Treatment decision 1

Discontinue the biologic before conception

She is educated on dietary control measures and lifestyle changes she can make to manage the disease whilst trying for a baby.
She is anxious she will lose control of her disease. In a Canadian study analysing PsA disease activity during pregnancy, 32% of patients had ongoing or high disease activity.²
Sandra is also very keen to breastfeed her baby; she's heard that up to 40% of women can suffer from post-partum flares in PsA²and is scared that, in order to control her disease, she may have to take a drug which is not compatible with breastfeeding.

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Treatment decision 2

Switch from a biologic that is contraindicated with pregnancy to another biologic that is not contraindicated with pregnancy, like Cimzia

Cimzia should only be used during pregnancy if clinically needed. Cimzia could be continued if Sandra decides she would like to breastfeed in the future. Sandra could remain on her current biologic if it was appropriate to use during breastfeeding.
Due to its inhibition of TNFa, Cimzia administered during pregnancy could affect normal immune response in the newborn.

Please refer to the Cimzia SmPC for further information.¹

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Treatment decision 3

Remain on the current biologic and then withdraw in the second trimester

Sandra is worried what might happen when she reaches the third trimester.

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Alternative scenario

Sandra was prescribed Cimzia first-line

Sandra has been on Cimzia monotherapy since she was diagnosed with PsA and failed traditional DMARD therapy. When she started Cimzia monotherapy, Sandra was not thinking about starting a family but found it comforting to hear that Cimzia can be used during pregnancy if clinically needed and breastfeeding, should her plans change in the future.

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How do you define best value?

Due to the emerging biosimilar market, NHS trusts are being encouraged to use the best value biologic as their first line option.³In addition to financial costs, it is important to consider the wider impact on the patient, their family and the NHS when a patient is on a treatment journey e.g. switching treatments, repeated hospital visits, loss of work days.⁴

Ultimately, a cost cannot be placed on the psychological aspects relating to the concerns of a woman trying for a baby, including being unfit to hold her newborn baby due to poor disease control.⁷

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Key assumptions

This decision tree should be used to make estimates for a given year. In a given year, some women will be pregnant, breastfeeding or may become pregnant in the following year. The calculations assume that breastfeeding women are not pregnant and will not become pregnant the following year.
Breastfeeding women are assumed to be those women who were pregnant in the previous year. In this regard, the calculation assumes that the same number of women who are pregnant in the current year, were pregnant in the previous year.

Cimzia should only be used during pregnancy if clinically needed

^a Biologic treatment options for people with PsA NICE minimum requirements:^21-25

The person has peripheral arthritis with three or more tender joints and three or more swollen joints, and
Their psoriatic arthritis has not been responded to adequate doses of at least two standard DMARDs, administered either individually or in combination

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NICE treatment options

(alternative requirements listed where relevant):

Adalimumab²¹

Cimzia²²The person has had, and stopped responding to, a TNF inhibitor after the first 12 weeks

Etanercept²¹

Golimumab²³

Infliximab²¹

Ixekizumab²⁴ The person has had, and stopped responding to a TNF inhibitor after or within the first 12 weeks, or TNF inhibitors are contraindicated

Seculkinumab²² The person has had, and stopped responding to a TNF inhibitor after or within the first 12 weeks, or TNF inhibitors are contraindicated

Ustekinumab^25,dTNF inhibitors are contraindicated, or the person has had treatment with 1 or more TNF inhibitors

^d The NICE minimum requirements listed above do not apply to ustekinumab, it can only be used in patients who meet the criteria listed under "Ustekinumab"²⁵

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Initiating and stabilising women on Cimzia^® where it is clinically indicated before conception may avoid a number of unnecessary costs, both financial and also administrative:

The numbers of patients considered for these calculations are taken from the figures presented for pregnant women, breastfeeding women and those women who fall pregnant the following year (planned and unplanned).

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It is assumed that 4 weeks are equivalent to 1 month and 13 weeks are equivalent to 3 months

Note that infliximab was excluded as it is administered in hospital and would not be given to patients to keep at home

^a Cost of biologic treatment in PsA to calculate potential medicines waste³⁰

^b Over 12 months:
Patients who continued: 1.6 flares
Patients who stopped/changed: 3.1 flares

^cThe cost was calculated by multiplying the average increase in flares (1.5) by attendance cost

^d A&E attendance for appropriate care without admission, assumed to require Category 2 Investigation with Category 3 Treatment at a Type 1 or 2 dept (HRG code VB05Z)

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